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Cpt Code 0275t Descriptive Essay

0275T is for a percutaneous approach
62287 is for needle based approach for removal of disc material
62380 is an endoscopic approach for laminotomy/discectomy
63030 is an open approach/direct visualization with laminotomy with discectomy for a herniated disc
63047 is an open approach/direct visualization for laminectomy/foraminotomy for spinal stenosis

0275T
Percutaneous laminotomy/laminectomy (interlaminar approach) for decompression of neural elements, (with or without ligamentous resection, discectomy, facetectomy and/or foraminotomy), any method, under indirect image guidance (eg, fluoroscopic, CT), single or multiple levels, unilateral or bilateral; lumbar

Excludes Laminotomy/hemilaminectomy by open and endoscopically assisted approach (63020-63035)
Excludes Percutaneous decompression of nucleus pulposus of intervertebral disc by needle-based technique (62287)

For non-needle based technique for percutaneous decompression of nucleus pulposus of intervertebral disc, see 0274T, 0275T)
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AMA CPT CHANGES 2017 (ALSO FOUND IN AMA CPT MANUAL PROFESSIONAL EDITION 2017)

Endoscopic Decompression of Neural Elements and/or Excision of Herniated Intervertebral Discs
Definitions For purposes of CPT coding, the following definitions of approach and visualization apply.

The primary approach and visualization define the service, whether another method is incidentally applied. Surgical services are presumed open, unless otherwise specified. Percutaneous: Image-guided procedures (eg, computer tomography [CT] or fluoroscopy) performed with indirect visualization of the spine without the use of any device that allows visualization through a surgical incision.

Endoscopic: Spinal procedures performed with continuous direct visualization of the spine through an endoscope. Open: Spinal procedures performed with continuous direct visualization of the spine through a surgical opening.

Indirect visualization: Image-guided (eg, CT or fluoroscopy), not light-based visualization.

Direct visualization: Light-based visualization; can be performed by eye, or with surgical loupes, microscope, or endoscope.

(For the techniques of microsurgery and/or use of microscope, use 69990)
(For percutaneous decompression, see 62287, 0274T, 0275T) ●

62380 Endoscopic decompression of spinal cord, nerve root(s), including laminotomy, partial facetectomy, foraminotomy, discectomy and/or excision of herniated intervertebral disc, 1 interspace, lumbar

Rationale
In accordance with the establishment of new definitions of key terms and operative approaches (including percutaneous, endoscopic, open, indirect visualization, and direct visualization) added to the code set for spinal procedures, a new subsection, heading, and code have been established for endoscopic decompression of neural elements and/or excision of herniated intervertebral disc procedures. The new definitions have also been included as guidelines under this new subsection. To align with the new definitions, a new subsection and heading were necessary to encompass the new endoscopic decompression procedure. Code 62380 has been established to report a lumbar endoscopic decompression procedure and includes laminotomy, partial facetectomy, foraminotomy, discectomy, and/or excision of herniated intervertebral disc for one interspace. Parenthetical notes have been added referencing codes 63030 and 63056 if an open procedure is performed, as described by the new definitions that distinguish open and endoscopic procedures. Modifier 50 for bilateral procedures should be appended to 62380 if a bilateral procedure is performed. In accordance with the establishment of the Endoscopic subsection and new code 62380, the percutaneous codes 62287, 0274T, and 0275T have been editorially revised by removing references to “endoscopic,” as the new definitions distinguish percutaneous and endoscopic procedures. Refer to the codebook and the Rationale for codes 62287, 0274T, and 0275T for a full discussion of these changes. Refer to the codebook and the Rationale for the new definitionsin the InjectionDrainage, or Aspiration heading in the Spine and Spinal Cord subsection for a full discussion of the changes.
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I am not aware of CMS covering this procedure other than for a clinical study. They implemented a national coverage determination policy that states that this percutaneous approach is not covered unless there is a specific clinical study being performed:

https://www.cms.gov/medicare-coverag...AAAAAAA%3d%3d&


National Coverage Determination (NCD) for Percutaneous image-guided lumbar decompression for lumbar spinal stenosis (150.13)

Number
100-3
Manual Section Number
150.13
Manual Section Title
Percutaneous image-guided lumbar decompression for lumbar spinal stenosis

Version Number
1
Effective Date of this Version
1/9/2014
Implementation Date
10/6/2014

Benefit Category
Outpatient Hospital Services Incident to a Physician's Service
Physicians' Services

Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description
A.*** General
PILD is a posterior decompression of the lumbar spine performed under indirect image guidance without any direct visualization of the surgical area. This is a procedure proposed as a treatment for symptomatic LSS unresponsive to conservative therapy. This procedure is generally described as a non-invasive procedure using specially designed instruments to percutaneously remove a portion of the lamina and debulk the ligamentum flavum. The procedure is performed under x-ray guidance (e.g., fluoroscopic, CT) with the assistance of contrast media to identify and monitor the compressed area via epiduragram.

Indications and Limitations of Coverage
B.*** Nationally Covered Indications
Effective for services performed on or after January 09, 2014, the Centers for Medicare & Medicaid Services (CMS) has determined that PILD will be covered by Medicare when provided in a clinical study under section 1862(a)(1)(E) through Coverage with Evidence Development (CED) for beneficiaries with LSS who are enrolled in an approved clinical study that meets the criteria below.
CMS has a particular interest in improved beneficiary function and quality of life, specific characteristics that identify patients who may benefit from the procedure, and the duration of benefit. A clinical study seeking Medicare payment for PILD for LSS must address one or more aspects of the following questions in a prospective, randomized, controlled design using current validated and reliable measurement instruments and clinically appropriate comparator treatments, including appropriate medical or surgical interventions or a sham controlled arm, for patients randomized to the non-PILD group.
The study protocol must specify a statistical analysis and a minimum length of patient follow up time that evaluates the effect of beneficiary characteristics on patient health outcomes as well as the duration of benefit.
Does PILD provide a clinically meaningful improvement of function and/or quality of life in Medicare beneficiaries with LSS compared to other treatments?
Does PILD provide clinically meaningful reduction in pain in Medicare beneficiaries with LSS compared to other treatments?
Does PILD affect the overall clinical management of LSS and decision making, including use of other medical treatments or services, compared to other treatments?
These studies must be designed so that the contribution of treatments in addition to the procedure under study are either controlled for or analyzed in such a way as to determine their impact.
The principal purpose of the research study is to test whether a particular intervention potentially improves the participants’ health outcomes.
The research study is well supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.
The research study does not unjustifiably duplicate existing studies.
The research study design is appropriate to answer the research question being asked in the study.
The research study is sponsored by an organization or individual capable of executing the proposed study successfully.
The research study is in compliance with all applicable Federal regulations concerning the protection of human subjects found at 45 CFR Part 46. If a study is regulated by the Food and Drug Administration (FDA), it must be in compliance with 21 CFR parts 50 and 56.
All aspects of the research study are conducted according to appropriate standards of scientific integrity (see http://www.icmje.org).
The research study has a written protocol that clearly addresses, or incorporates by reference, the standards listed here as Medicare requirements for CED coverage.
The clinical research study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Trials of all medical technologies measuring therapeutic outcomes as one of the objectives meet this standard only if the disease or condition being studied is life threatening as defined in 21 CFR § 312.81(a) and the patient has no other viable treatment options.
The clinical research study is registered on the ClinicalTrials.gov website by the principal sponsor/investigator prior to the enrollment of the first study subject.
The research study protocol specifies the method and timing of public release of all prespecified outcomes to be measured including release of outcomes if outcomes are negative or study is terminated early. The results must be made public within 24 months of the end of data collection. If a report is planned to be published in a peer reviewed journal, then that initial release may be an abstract that meets the requirements of the International Committee of Medical Journal Editors (http://www.icmje.org).
The research study protocol must explicitly discuss subpopulations affected by the treatment under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion criteria effect enrollment of these populations, and a plan for the retention and reporting of said populations on the trial. If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment or retention of underrepresented populations, the protocol must discuss why these criteria are necessary.
The research study protocol explicitly discusses how the results are or are not expected to be generalizable to the Medicare population to infer whether Medicare patients may benefit from the intervention. Separate discussions in the protocol may be necessary for populations eligible for Medicare due to age, disability or Medicaid eligibility.
Consistent with section 1142 of the Social Security Act, the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS determines meet the above-listed standards and address the above-listed research questions.
C.*** Nationally Non-Covered Indications
Effective for services performed on or after January 09, 2014, CMS has determined that PILD for LSS is not reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act.
D. ***Other
Endoscopically assisted laminotomy/laminectomy, which requires open and direct visualization, as well as other open lumbar decompression procedures for LSS are not within the scope of this NCD.

Claims Processing Instructions
TN 2959 (Medicare Claims Processing)*
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Here is from WPS Medicare J5 LCD for Category III codes


Group*2*Paragraph:*For claims with dates of service on or after January 9, 2014, PILD, procedure code 0275T, is a covered service only when billed as part of a clinical trial approved by CMS per NCD-150.13. All Percutaneous Image-Guided Lumbar Decompression for Lumbar Spinal Stenosis (PILD for LSS) claims:
12/31/2014 and earlier should be processed with code 0275T.
01/01/2015 and after use 2 different codes:
- G0276 for clinical trial with Identifier NCT02079038. Is a blinded randomized controlled clinical trial which includes a CMS-approved placebo procedure arm (See CR 8954);
- 0275T for all other clinical trials (See CR 8757).


Group*2*Codes:

0275T
PERCUTANEOUS LAMINOTOMY/LAMINECTOMY (INTERLAMINAR APPROACH) FOR DECOMPRESSION OF NEURAL ELEMENTS, (WITH OR WITHOUT LIGAMENTOUS RESECTION, DISCECTOMY, FACETECTOMY AND/OR FORAMINOTOMY), ANY METHOD, UNDER INDIRECT IMAGE GUIDANCE (EG, FLUOROSCOPIC, CT), SINGLE OR MULTIPLE LEVELS, UNILATERAL OR BILATERAL; LUMBAR

Last edited by dwaldman; 04-22-2017 at 06:34 PM.

Number: 0016

Policy

Aetna considers any of the following injections or procedures medically necessary for the treatment of back pain; provided, however, that only 1 invasive modality or procedure will be considered medically necessary at a time.

  1. Facet joint injections

     (intra-articular and medial branch blocks) are considered medically necessary in the diagnosis of facet pain in persons with severe chronic neck and back pain that limits daily activities and has lasted more than 3 months despite appropriate conservative treatment (including, but not limited to rest, systemic medications, and/or physical therapy), with symptoms suggestive of facet joint syndrome (symptoms of facet joint syndrome include absence of radiculopathy, pain that is aggravated by extension, rotation or lateral bending of the spine and is not typically associated with any neurological deficits), where facet mediated pain is confirmed by provocative testing on physical examination (to confirm that pain is exacerbated by extension and rotation), imaging studies suggest no other obvious cause of pain, and radiofrequency facet neurolysis is being considered.

    Diagnostic facet joint injections are considered experimental and investigational for neck and back pain with untreated radiculopathy. Facet joint injections (intra-articular and medial branch blocks) are considered experimental and investigational as therapy for back and neck pain and for all other indications because their effectiveness for these indications has not been established. Aetna considers diagnostic facet joint injections not medically necessary where radiofrequency facet neurolysis is not being considered.

    A set of facet joint injections (intra-articular or medial branch blocks) means up to 6 such injections per sitting, and this can be repeated once at the same levels and side, no sooner than one week after the initial set of injections, to establish the diagnosis.  Additional sets of facet injections or medial branch blocks at the same levels and side are considered experimental and investigational because they have no proven value. 

    Aetna considers ultrasound guidance of facet injections experimental and investigational because of insufficient evidence of its effectiveness. 

  2. Trigger point injections

    of corticosteroids and/or local anesthetics, are considered medically necessary for treating members with chronic neck or back pain or myofascial pain syndrome, when all of the following selection criteria are met:

    1. Conservative treatment such as bed rest, exercises, heating or cooling modalities, massage, and pharmacotherapies such as non-steroidal anti-inflammatory drugs (NSAIDS), muscle relaxants, non-narcotic analgesics, should have been tried and failed, and

    2. Symptoms have persisted for more than 3 months, and

    3. Trigger points have been identified by palpation; and

    4. Trigger point injections are not administered in isolation, but are provided as part of a comprehensive pain management program, including physical therapy, patient education, psychosocial support, and oral medication where appropriate.

    Trigger point injections are considered experimental and investigational for all other indications because their effectiveness for indications other than the ones listed above has not been established.

    A trigger point is defined as a specific point or area where, if stimulated by touch or pressure, a painful response will be induced.  A set of trigger point injections means injections in several trigger points in one sitting.  It is not considered medically necessary to repeat injections more frequently than every 7 days.  Up to 4 sets of injections are considered medically necessary to diagnose the origin of a patient's pain and achieve a therapeutic effect; additional sets of trigger point injections are not considered medically necessary if no clinical response is achieved.  Once a diagnosis is established and a therapeutic effect is achieved, it is rarely considered medically necessary to repeat trigger point injections more frequently than once every 2 months.  Repeated injections extending beyond 12 months may be reviewed for continued medical necessity.

  3. Sacroiliac joint injections

    are considered medically necessary to relieve pain associated with lower lumbosacral disturbances in members who meet both of the following criteria:

    1. Member has back pain for more than 3 months; and
    2. The injections are not used in isolation, but are provided as part of a comprehensive pain management program, including physical therapy, patient education, psychosocial support, and oral medication where appropriate.

    Sacroiliac joint injections are considered experimental and investigational for all other indications because their effectiveness for indications other than the ones listed above has not been established.

    Up to 2 sacroiliac injections are considered medically necessary to diagnose the patient's pain and achieve a therapeutic effect.  It is not considered medically necessary to repeat these injections more frequently than once every 7 days.  If the member experiences no symptom relief or functional improvement after 2 sacroiliac joint injections, additional sacroiliac joint injections are not considered medically necessary.  Once the diagnosis is established, it is rarely medically necessary to repeat sacroiliac injections more frequently than once every 2 months.  Repeat injections extending beyond 12 months may be reviewed for continued medical necessity.  Ultrasound guidance of sacroiliac joint injections is considered not medically necessary.

  4. Interlaminar epidural injections

    of corticosteroid preparations (e.g., Depo-Medrol), with or without added anesthetic agents, are considered medically necessary in the outpatient setting for management of persons with radiculopathy or sciatica when all of the following are met:

    1. Pain is radicular in nature (radicular signs may include, but are not limited to, a positive straight leg raise or a dermatomal pattern of sensory loss). Note: In low back pain, radicular means pain and/or numbness that radiates below the knee; in neck pain, it is pain, numbness or weakness in the shoulder, arm, wrist or hand.
    2. Intraspinal tumor or other space-occupying lesion, or non-spinal origin for pain, has been ruled out as the cause of pain; and

    3. Member has failed to improve after 4 or more weeks of conservative treatments (e.g., rest, systemic analgesics and/or physical therapy); and

    4. Interlaminar epidural injections are provided as part of a comprehensive pain management program, which includes physical therapy, patient education, psychosocial support, and oral medications, where appropriate.

    Interlaminar epidural injections of corticosteroid preparations, with or without added anesthetic agents, are considered experimental and investigational for all other indications (e.g., non-specific low back pain [LBP] and failed back syndrome) because their effectiveness for indications other than the ones listed above has not been established.

    Initially, the individual may receive the first three injections at intervals of no sooner than two weeks. If the initial interlaminar epidural injections are unsuccessful, additional interlaminar epidural injections are considered not medically necessary. Note: A successful interlaminar injection is one in which there is a 50% reduction in pain and/or symptoms. 

    Interlaminar epidural injections beyond the first three are considered medically necessary, if the initial injections resulted in at least a 50% relief in pain and/or symptoms, and the interlaminar epidural injections are provided as part of a comprehensive pain management program, which includes physical therapy, patient education, psychosocial support, and oral medications, where appropriate. If the member experiences less than 50% relief of pain after three interlaminar epidural injections, additional epidural injections are not considered medically necessary. After the initial three injections, repeat epidural injections more frequently than every two months are not considered medically necessary.  A total of four interlaminar epidural steroid injections per region (ie, cervical, thoracic, lumbar) per rolling 12-month period are considered medically necessary, only upon return of pain and/or deterioration in function and only when responsiveness to prior injections has occurred (ie, the individual should have at least a 50% reduction in pain and/or symptoms for two months). Additional interlaminar epidural injections per region per rolling 12-month period are considered experimental and investigational because they have no proven value. 

    Aetna considers ultrasound guidance of epidural injections experimental and investigational because of insufficient evidence of its effectiveness.

    For transforaminal epidural injections, see CPB 0722 - Selective Nerve Root Blocks

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  5. Chymopapain chemonucleolysis

    is considered medically necessary for the treatment of sciatica due to a herniated disc when all of the following are met:

    1. Member has leg pain worse than LBP; and

    2. Member has radicular symptoms reproduced by sciatic stretch tests; and

    3. Member has only a single-level herniated disc with nerve root impingement at clinically suspected level demonstrated by MRI, CT, or myelography; and

    4. Member has objective neurologic deficit (e.g., diminished deep tendon reflex, motor weakness, or hypalgesia in dermatomal distribution); and

    5. Pain not relieved by at least 6 weeks of conservative treatments.

    Chymopapain chemonucleolysis is considered experimental and investigational for all other indications, including the following because its effectiveness for these indications has not been established:

    1. Acute LBP alone

    2. Cauda equina syndrome

    3. For herniated thoracic or cervical discs

    4. Multiple back operations (failed back surgery syndrome)

    5. Neurologic disease (e.g., multiple sclerosis)

    6. Pregnancy

    7. Profound or rapidly progressive neurologic deficit

    8. Sequestered disc fragment

    9. Severe spinal stenosis

    10. Severe spondylolisthesis

    11. Spinal cord tumor

    12. Spinal instability

    13. When performed with chondroitinase ABC or agents other than chymopapain

  6. Percutaneous lumbar discectomy

    , manual or automated, is considered medically necessary for treatment of herniated lumbar discs when all of the following are met:

    1. Member is otherwise a candidate for open laminectomy; and
    2. Member has failed 6 months of conservative treatment; and
    3. Diagnostic studies show that the nuclear bulge of the disc is contained within the annulus (i.e., the herniated disc is contained); and
    4. Member has no previous surgery or chemonucleolysis of the disc to be treated; and
    5. Member must have typical clinical symptoms of radicular pain corresponding to the level of disc involvement.

    Percutaneous lumbar diskectomy is considered experimental and investigational for all other indications because its effectiveness for indications other than the one listed above has not been established.

    Note: Clinical studies have not established any clinically significant benefit of use of a laser over use of a scalpel for percutaneous lumbar diskectomy.

  7. Non-pulsed radiofrequency facet denervation

    (also known as facet neurotomy, facet rhizotomy, or articular rhizolysis) is considered medically necessary for treatment of members with intractable cervical or back pain with or without sciatica in the outpatient setting when all of the following are met:

    1. Member has experienced severe pain limiting activities of daily living for at least 6 months; and

    2. Member has had no prior spinal fusion surgery at the level to be treated; and

    3. Neuroradiologic studies are negative or fail to confirm disc herniation; and

    4. Member has no significant narrowing of the vertebral canal or spinal instability requiring surgery; and

    5. Member has tried and failed conservative treatments such as bed rest, back supports, physiotherapy, correction of postural abnormality, as well as pharmacotherapies (e.g., anti-inflammatory agents, analgesics and muscle relaxants); and

    6. Trial of facet joint injections has resulted in a significant reduction in pain. Significant reduction in pain after a diagnostic facet joint injection is defined as a 50% or greater reduction in pain and/or symptoms. 

    Non-pulsed radiofrequency facet denervation is considered experimental and investigational for all other indications because its effectiveness for indications other than the ones listed above has not been established.

    Provided that greater than 50% pain relief is obtained for at least twelve weeks, further facet denervation procedures should be at intervals of at least six months per level per side, at a maximum of twice per rolling calendar year. Only 1 treatment procedure per level per side is considered medically necessary in a 6-month period.

    See also CPB 0735 - Pulsed Radiofrequency.

  8. Pedicle screws for spinal fixation

    are considered medically necessary for the following indications:

    1. Fusion adjacent to prior lumbar fusion

    2. Fusion after decompression

    3. Pseudoarthrosis repair

    4. Revision lumbar disc surgery requiring instrumentation because of instability at the previous level of surgery

    5. Scoliosis and kyphosis requiring spinal instrumentation

    6. Segmental defects or loss of posterior elements following tumor resection

    7. Spinal trauma of all types including fractures and dislocations

    8. Spondylolisthesis -- grades I to IV

    9. Thoracic fractures

    Pedicle screw fixation is considered experimental and investigational for all other indications, including the following because its effectiveness for indications other than the ones listed above has not been established:

    1. Decompressive laminectomy for spinal stenosis without evidence of instability

    2. Degenerative disc disease

    3. Failed lumbar surgery without documentation of instability pattern or pseudarthrosis

    4. First time intervertebral disc herniation

    5. Isolated LBP without spinal instability or neurologic deficits

    6. Single-level discectomy 
       

  9. Intervertebral body fusion devices

    (spine cages) (see appendix) are considered medically necessary for use with allograft or autogenous bone graft in members who meet criteria for lumbar spinal fusion as outlined in CPB 0743 Spinal Surgery: Laminectomy and Fusion and for thoracic fusion.  Spine cages for cervical fusion are considered medically necessary for members who meet criteria in CPB 0743 Spinal Surgery: Laminectomy and Fusion with any the following indications for use of a cervical cage: 

    1. Cervical corpectomy (removal of half or more of vertebral body, not mere removal of osteophytes and minor decompression) in the treatment of one of the following:

      1. For tumors involving one or more vertebrae, or
      2. Greater than 50 % compression fracture of vertebrae, or
      3. Retropulsed bone fragments, or
      4. Symptomatic central canal stenosis caused by vertebral body pathology (such as due to fracture, tumor or congenital or acquired deformity of the vertebral body).
         
    2. Multilevel (3 or more vertebral bodies) cervical fusion for pseudarthrosis in persons with prior fusion; or
    3. For adjacent level disease that has developed in persons with a prior cervical fusion involving a plate, in order to avoid dissection for plate removal; or
    4. Multilevel (3 or more discs) cervical discectomy in persons meeting criteria for cervical discectomy in CPB 0743 - Spinal Surgery: Laminectomy and Fusion; or
    5. Persons with religious or cultural beliefs that preclude the use of cadaver bone, such as the Native American population in the Southwestern United States, who have poor bone stock (e.g., due to osteoporosis, osteogenesis imperfecta, ESRD, diabetes, long-term steroid use, immunosuppression after transplant, or parathyroid deficiency).

      Spine cages are otherwise not considered medically necessary for cervical fusion because they have not been proven more effective than bone graft for this indication.

      Spine cages are considered experimental and investigational for indications other than fusion because their effectiveness for indications other than those listed above has not been established.

      Expandable cages are considered medically necessary for persons who meet criteria for fusion in CPB 0743 - Spinal Surgery: Laminectomy and Fusion, and who meet either of the following criteria: 1) At L5-S1, where disc morphologic is hard to reconstruct using standard, static cages; or 2) for persons with osseous defects at the fusion site (i.e., voids or gaps in bone due to trauma, surgical resection or congenital defects). Expandable cages are considered experimental and investigational for all other indications.
       
  10. Percutaneous polymethylmethacrylate vertebroplasty (PPV) or kyphoplasty

    is considered medically necessary for members with persistent, debilitating pain in the cervical, thoracic or lumbar vertebral bodies resulting from any of the following:
     

    1. Multiple myeloma; or
    2. Painful and/or aggressive hemangiomas; or

    3. Painful vertebral eosinophilic granuloma; or

    4. Painful, debilitating osteoporotic collapse/compression fractures (e.g., Kummell's disease); or

    5. Primary malignant neoplasm of bone or bone marrow; or

    6. Secondary osteolytic metastasis, excluding sacrum and coccyx; or

    7. Steroid-induced fractures

    AND all of the following criteria have been met:

    1. Other causes of pain such as herniated intervertebral disk have been ruled out by computed tomography or magnetic resonance imaging; and

    2. Severe debilitating pain or loss of mobility that cannot be relieved by optimal medical therapy (e.g., acetaminophen, NSAIDS, narcotic analgesics, braces, physical therapy, etc.); and

    3. The affected vertebra has not been extensively destroyed and is at least 1/3 of its original height.
       
  11. Lateral (including extreme [XLIF], extra and direct lateral [DLIF]) interbody fusion

    is considered an acceptable method of performing a medically necessary anterior interbody fusion. See CPB 0743 Spinal Surgery: Laminectomy and Fusionuyftcvyuffwtzvdutrywwxtx.

  12. Coccygectomy

    is considered medically necessary for individuals with coccygodynia who have tried and failed to respond to 6 months of conservative management.

  13. Vertebral body replacement spacers

    (e.g., AVS AL PEEK Spacer) are considered medically necessary for vertebral body replacement used in spine surgery for persons with a collapsed, damaged or unstable vertebral body resected or excised during total and partial vertebrectomy procedures due to tumor or trauma (vertebral body replacement should not be confused with Interspinous distraction devices (spacers) (e.g., X-Stop)).

  14. Minimally invasive transforaminal lumbar interbody fusion with direct visualization

    is considered medically necessary when criteria are met in CPB 0743 - Spinal Surgery: Laminectomy and Fusion.

For intercostal nerve blocks, see CPB 0863 - Peripheral Nerve Blocks.

Experimental and Investigational Interventions

Aetna considers any of the following injections or procedures experimental and investigational: 

  • AccuraScope procedure;
  • Annulus repair devices (Xclose Tissue Repair System, Barricaid, Disc Annular Repair Technology (DART) System) 
  • BacFast HD for isolated facet fusion;
  • Chemical ablation (including but not limited to alcohol, phenol or sodium morrhuate) of facet joints;
  • Coccygeal ganglion (ganglion impar) block for coccydynia, pelvic pain, and all other indications;
  • Cryoablation (cryoanesthesia, cryodenervation, cryoneurolysis, or cryosurgery) for the treatment of lumbar facet joint pain;
  • Deuk Laser Disc Repair;
  • Devices for annular repair (e.g., Inclose Surgical Mesh System);
  • Dynamic (intervertebral) stabilization (e.g., BioFlex, CD Horizon Agile Dynamic Stabilization Device, DSS Dynamic Soft Stabilization System, Dynabolt  Dynamic Stabilization System, Dynesys Spinal System, Graf ligamentoplasty/Graf artificial ligament, Isobar Spinal System, NFix, Satellite Spinal System, Stabilimax NZ Dynamic Spine Stabilization System, and the Zodiak DynaMo System);
  • Endoscopic disc decompression, ablation, or annular modulation using the DiscFX System;
  • Endoscopic laser foraminoplasty, endoscopic foraminotomy, laminotomy, and rhizotomy (endoscopic radiofrequency ablation);
  • Endoscopic transforaminal diskectomy;
  • Epidural fat grafting during lumbar decompression laminectomy/discectomy;
  • Epidural injections of lytic agents (e.g., hyaluronidase, hypertonic saline) or mechanical lysis in the treatment of adhesive arachnoiditis, epidural fibrosis, failed back syndrome, or other indications;
  • Epidural steroid injections for the treatment of non-radicular low back pain;
  • Epiduroscopy (also known as epidural myeloscopy, epidural spinal endoscopy, myeloscopy, and spinal endoscopy) for the diagnosis and treatment of intractable LBP or other indications;
  • Facet chemodenervation/chemical facet neurolysis;
  • Facet joint allograft implants (NuFix facet fusion, TruFuse facet fusion)
  • Facet joint implantation (Total Posterior-element System (TOPS) (Premia Spine), Total Facet Arthroplasty System (TFAS) (Archus Orthopedics), ACADIA Facet Replacement System (Facet Solutions/Globus Medical);
  • Far lateral microendoscopic diskectomy (FLMED) for extra-foraminal lumbar disc herniations or other indications;
  • Hardware injections/blocks;
  • Interlaminar lumbar instrumented fusion (ILIF);
  • Interspinous and interlaminar distraction devices (see Appendix);
  • Interspinous fixation devices (CD HORIZON SPIRE Plate, PrimaLOK SP, SP-Fix Spinous Process Fixation Plate, and Stabilink interspinous fixation device) for spinal stenosis or other indications (see Appendix)
  • Intradiscal, paravertebral, or epidural oxygen or ozone injections;
  • Intradiscal steroid injections;
  • Intravenous administration of corticosteroids, lidocaine, magnesium, Toradol or vitamin B12 (cyanocobalamin) as a treatment for back pain;
  • Khan kinetic treatment (KKT);
  • Laser facet denervation;
  • Least invasive lumbar decompression interbody fusion (LINDIF);
  • Microendoscopic discectomy (MED; same as lumbar endoscopic discectomy utilizing microscope) procedure for decompression of lumbar spine stenosis, lumbar disc herniation, or other indications;
  • Microsurgical anterior foraminotomy for cervical spondylotic myelopathy or other indications;
  • Microsurgical lumbar sequestrectomy for the treatment of lumbar disc herniation;
  • Minimally invasive/endoscopic cervical laminoforaminotomy for cervical radiculopathy/lateral and foraminal cervical disc herniations or other indications;
  • Minimally invasive lumbar decompression (MILD) procedure (percutaneous laminotomy/laminectomy (interlaminar approach) for decompression of neural elements under indirect image guidance) for lumbar canall stenosis or other indications;
  • Minimally invasive thoracic discectomy for the treatment of back pain;
  • Minimally invasive endoscopic transforaminal lumbar interbody fusion (endoscopic MITLIF; same as endoscopic MAST fusion) for lumbar disc degeneration and instability or other indications;
  • OptiMesh grafting system;
  • Percutaneous cervical diskectomy;
  • Percutaneous endoscopic diskectomy with or without laser (PELD) (also known as arthroscopic microdiskectomy or Yeung Endoscopic Spinal Surgery System [Y.E.S.S.]);
  • Piriformis muscle resection and other surgery for piriformis syndrome;
  • Psoas compartment block for lumbar radiculopathy or myositis ossification;
  • Racz procedure (epidural adhesiolysis with the Racz catheter) for the treatment of members with adhesive arachnoiditis, epidural adhesions, failed back syndrome from multiple previous surgeries for herniated lumbar disk, or other indications;
  • Radiofrequency denervation for sacroiliac joint pain;
  • Radiofrequency lesioning of dorsal root ganglia for back pain;
  • Radiofrequency lesioning of terminal (peripheral) nerve endings for back pain;
  • Radiofrequency/pulsed radiofrequency ablation of trigger point pain;
  • Sacroiliac fusion or pinning for the treatment of LBP due to sacroiliac joint syndrome; Note: Sacroiliac fusion may be medically necessary for sacroiliac joint infection, tumor involving the sacrum, and sacroiliac pain due to severe traumatic injury where a trial of an external fixator is successful in providing pain relief;
  • Sacroiliac joint fusion (e.g., by means of the iFuse System and the SImmetry Sacroiliac Joint Fusion System);
  • Sacroplasty for osteoporotic sacral insufficiency fractures and other indications;
  • Total Facet Arthroplasty System (TFAS) for the treatment of spinal stenosis;
  • Vesselplasty (e.g., Vessel-X).

See also CPB 0602 - Thermal Intradiscal Procedure.

Reimbursement Notes:

  • Laser:

    Clinical studies have not established a clinically significant benefit of use of a laser over a scalpel in spinal surgery.  No additional benefit will be provided for the use of a laser in spinal surgery.

  • Microscope and endoscope:

    Use of a microscope or endoscope is considered an integral part of the spinal surgery and not separately reimbursable.

Background

Epidural Steroids

An epidural steroid finjection is an injection of long lasting steroid in the epidural space -- that is the area which surrounds the spinal cord and the nerves coming out of it. An epidural steroid injection is used to help reduce radicular spinal pain that may be caused by pressure on a spinal nerve root as a result of a herniated disc, degenerative disc disease or spinal stenosis. This treatment is most frequently used for low back pain, though it may also be used for cervical (neck) or thoracic (midback) pain. A combination of an anesthetic and a steroid medication is injected into the epidural space near the affected spinal nerve root with the assistance of fluoroscopy which allows the physician to view the placement of the needle.

Approaches to the epidural space for the injection include:

  • Caudal –

    the epidural needle is placed into the tailbone (coccyx) allowing the treatment of pain which radiates into the lower extremities. This approach is commonly used to treat lumbar radiculopathy after prior surgery in the low back (post-laminectomy pain syndrome).

  • Cervical –

    the epidural needle is placed in the midline in the back of the neck to treat neck pain which is associated with radiation of pain into an upper extremity (cervical radiculopathy).

  • Interlaminar –

    the needle is placed between the lamina of two vertebrae directly from the middle of the back. Also called translaminar, this method accesses the large epidural space overlying the spinal cord, and is the most commonly used approach for cervical, thoracic, and lumbar epidural injections. Medication is delivered to the nerve roots on both the right and left sides of the inflamed area at the same time.

  • Lumbar –

    the epidural needle is placed in the midline in the low back to treat back pain which is associated with radiation into a lower extremity (lumbar radiculopathy).

  • Thoracic –

    the epidural needle is placed in the midline in the upper or middle back.

  • Transforaminal –

    the needle is placed to the side of the vertebra in the neural foramen, just above the opening for the nerve root and outside the epidural space; this method treats one side at a time.

The goal of this treatment is to reduce inflammation and block the spinal nerve roots to relieve radicular pain or sciatica. It can also provide sufficient pain relief to allow the individual to progress with their rehabilitation program.

The efficacy of epidurally administered steroids has been demonstrated without adverse consequence in a large number of patients with reproducible results.  In a large number of studies, long-term relief of pain (greater than 3 months) can be achieved in at least 10 to 30 % of patients, while short-term relief (less than 1 month) can be achieved in 60 to 100 % of patients.  Results for cervical pain are somewhat lower than those for lumbar pain.  Such therapy is considered under accepted guidelines to be indicated in patients with low back and cervical pain that has not resolved after only a short period of more conservative measures since studies have shown a better response to therapy in patients whose pain is of shorter duration.  Even if pain relief is temporary, it may have long-term benefit because it allows initiation of physical therapy or other rehabilitative measures at an earlier stage.  Most authors indicate that a limit on number of injections is appropriate, and that most patients will respond with 3 or fewer injections.

The American Academy of Neurology's assessment on the use of epidural steroid injections in the treatment of radicular lumbosacral pain (Armond et al, 2007) concluded that:

  • Epidural steroid injections may result in some improvement in radicular lumbosacral pain when determined between 2 and 6 weeks following the injection, compared to control treatment (Level C, Class I to III evidence).  The average magnitude of effect is small, and the generalizability of the observation is limited by the small number of studies, limited to highly selected patient populations, the few techniques and doses studied, and variable comparison treatments.

  • In general, epidural steroid injections for radicular lumbosacral pain have shown no impact on average impairment of function, on need for surgery, or on long-term pain relief beyond 3 months.  Their routine use for these indications is not recommended (Level B, Class I to III evidence).

  • Data on use of epidural steroid injections to treat cervical radicular pain are inadequate to make any recommendation (Level U).

Guidelines from the American Pain Society (Chou et al, 2009) questioned the clinical value of epidural injection for long-term use or for use of non-radicular back pain.  A recommendation for epidural steroid injection for patients with symptomatic spinal stenosis was not offered based on insufficient or poor evidence.

Langer-Gould et al (2013) discussed the American Academy of Neurology (AAN)'s top five recommendations in the “Choosing Wisely” campaign promoting high-value neurologic medicine and physician-patient communication.  They noted that 1 of the 11 finalist recommendations was “Don’t perform epidural steroid injections to treat non-radicular low back pain”.

Trigger Point Injections

Trigger point injections (TPI) are injections of saline or a local anesthetic, with or without a steroid medication, into a painful area of a muscle that contains the trigger point. The purpose of a TPI is to relax the area of intense muscle spasm, effectively inactivate the trigger point and provide prompt symptomatic pain relief. TPI is the most common interventional technique used in pain medicine.

Trigger points have also been treated with dry needling. Dry needling is not to be confused with traditional Chinese acupuncture, even though it does make use of acupuncture-type needles. Acupuncture follows the principles of energy flow as a guide to where the needles will be inserted; in dry needling, needles are inserted directly into a myofascial trigger point, in an attempt to inactivate it, thereby decreasing the associated pain. Dry needling, even though it targets a trigger point, also differs from a trigger point injection, as there is no injection of medication or fluid.

A myofascial trigger point is a discrete focal tenderness, 2-5 mm in diameter that is located in distinct tight bands or knots of skeletal muscle (AHFMR, 2002).  When palpated, these hyper-irritable areas cause pain in distant areas, or referred pain zones, which are specific for each trigger point.  Trigger point injection, or direct wet needling, involves injection of fluid directly into the trigger point located in the taut muscle band.  The main objective of trigger point injection is fast pain relief and elimination of muscle spasm in order to break the pain cycle.  This facilitates physical therapy aimed at reducing muscle contracture and increasing range of motion.  Trigger point injection is rarely used in isolation but is generally part of a multi-disciplinary approach aimed at treating both the trigger points and reducing all contributing factors (Scott and Guo, 2005; AHFMR, 2002; Sanders et al, 1999).  Thus, treatment may also include patient education, psychosocial support, oral medications, and physical therapy to improve the strength and flexibility of the affected musculoskeletal systems.  An assessment conducted by the Alberta Heritage Foundation for Medical Research (Scott and Guo, 2005) found that the evidence for the effectiveness of trigger point injections when used as the sole treatment for patients with chronic head, neck, and shoulder pain and whiplash syndrome was inconclusive, regardless of whether sterile water, saline, or botulinum toxin is injected.  The assessment found that the combined use of dry needling and trigger point injection with procaine offers no obvious clinical benefit in the treatment of chronic craniofacial pain, while the effectiveness of trigger point injection for the treatment of cervicogenic headache is unknown.  In contrast, the assessment found that trigger point injection with lidocaine may be useful in the treatment of joint pain caused by osteoarthritis (Scott and Guo, 2005).  The assessment found no proof that triggers point injection is more effective than other less invasive treatments, such as physical therapy and ultrasound, in achieving pain relief, and there is some suggestion that the only advantage of injecting anesthetic into trigger points is that it reduces the pain of the needling process (Scott and Guo, 2005).  Usually, approximately 3 treatments are necessary to abolish a trigger point completely (AHFMR, 2002).  A number of trigger points may be injected in 1 session, but rarely more than 5.  Repeated injections in a particular muscle are not recommended if 2 or 3 previous attempts have been unsuccessful (Alvarez and Rockwell, 2002; Sanders et al, 1999).  The pain relief may last for the duration of the anesthetic to many months, depending on the chronicity and severity of the trigger points and the concomitant treatment of perpetuating factors.  According to available guidelines, use of trigger point injections should be short-term and part of a comprehensive rehabilitation program.  Available guidelines indicate that, while there are a number of uncontrolled case studies using trigger point injections in more acute pain presentations, there is virtually no consistent evidence for its application with chronic non-malignant pain syndrome patients to date (Sanders et al, 1999; AHFMR, 2002).

Lumbar Laminectomy with or without Fusion

Laminectomy and laminotomy involve removal of a small part of the bony arches of the spinal canal, called the lamina, which increases the size of the spinal canal. A laminectomy or laminotomy is most commonly performed for a diagnosis of spinal stenosis. During a laminectomy the entire lamina is removed while only a portion of the lamina is removed in a laminotomy. These procedures are also often done with either a discectomy or a foraminectomy/foraminotomy.

Most individuals with acute low back problems spontaneously recover activity tolerance within 4 to 6 weeks of conservative therapy (AHCPR, 1994).  Conservative therapy for acute low back pain (LBP) includes:

  • Avoidance of activities that aggravate pain
  • Chiropractic manipulation in the first 4 weeks if no radiculopathy
  • Cognitive support and reassurance that recovery is expected
  • Education regarding spine biomechanics
  • Exercise program
  • Heat/cold modalities for home use
  • Limited bed rest with gradual return to normal activities
  • Low impact exercise as tolerated (e.g., walking, swimming, stationary bike)
  • Non-narcotic analgesics
  • Pharmacotherapy (e.g., non-narcotic analgesics, non-steroidal anti-inflammatory drugs [NSAIDs] (as second-line choices), avoid muscle relaxants, or only use during the first week, avoid narcotics).

If conservative therapy fails to relieve symptoms of sciatica and radiculopathy and there is strong evidence of dysfunction of a specific nerve root confirmed at the corresponding level by findings demonstrated by CT/MRI, lumbar laminectomy may be proposed as a treatment option.  The goal of lumbar laminectomy is to provide decompression of the affected nerve root to relieve the individual's symptoms.  It involves the removal of all or part of the lamina of a lumbar vertebra.  The addition of fusion with or without instrumentation is considered when there are concerns about instability.

Decompression with or without Discectomy for Cauda Equine Syndrome

Cauda equina ("horse's tail") is the name given to the lumbar and sacral nerve roots within the dural sac caudal to the conus medullaris.  Cauda equina syndrome is usually the result of a ruptured, midline intervertebral disk, most commonly occurring at the L4 to L5 level.  However, tumors and other compressive masses may also cause the syndrome.  Individuals generally present with progressive symptoms of fecal or urinary incontinence, impotence, distal motor weakness, and sensory loss in a saddle distribution.  Muscle stretch reflexes may also be reduced.  The presence of urinary retention is the single most consistent finding (Perron and Huff, 2002).

In acute cauda equine syndrome, surgical decompression as soon as possible is recommended.  In a more chronic presentation with less severe symptoms, decompression could be performed when medically feasible and should be delayed to optimize the patient's medical condition; with this precaution, decompression is less likely to lead to irreversible neurological damage (Dawodu, 2005).

Cervical Laminectomy with or without Fusion

A cervical laminectomy (may be combined with an anterior approach) is sometimes performed when acute cervical disc herniation causes central cord syndrome or in cervical disc herniations refractory to conservative measures.  Studies have shown that an anterior discectomy with fusion is the recommended procedure for central or anterolateral soft disc herniation, while a posterior laminotomy-foraminotomy may be considered when technical limitations for anterior access exist (e.g., short thick neck) or when the individual has had prior surgery at the same level (Windsor, 2006).

Discectomy alone is regarded as a technique that most frequently results in spontaneous fusion (70 to 80 %).  Additional fusion techniques include the use of bone grafts (autograft, allograft or artificial) with or without cages and/or the use of an anterior plate.  Based on the clinical evidence, autologous or cadaveric bone grafting, with or without plating, remains the gold standard for cervical fusion. Therefore, use of an intervertebral cage for cervical fusion is considered experimental and investigational. A Cochrane systematic review (2004) reported the results of fourteen studies (n = 939) that evaluated three comparisons of different fusion techniques for cervical degenerative disc disease and concluded that discectomy alone has a shorter operation time, hospital stay, and post-operative absence from work than discectomy with fusion with no statistical difference for pain relief and rate of fusion.  The authors concluded that more conservative techniques (discectomy alone, autograft) perform as well or better than allograft, artificial bone, and additional instrumentation; however, the low quality of the trials reviewed prohibited extensive conclusions and more studies with better methodology and reporting are needed.

An assessment by the BlueCross BlueShield Association Technology Evaluation Center (BCBSA, 2014) stated: "The choice of bone material for interbody fusion in [anterior cervical discectomy and fusion] ACDF has important clinical implications. Allograft bone has several drawbacks, including a minute (albeit unproven) risk of infectious disease transmission; possible immunological reaction to the allograft; and possible limited commercial availability of appropriate graft material. In contrast, the use of autograft bone in ACDF has potentially substantial morbidities at the harvest site, generally the iliac crest. These include moderate-to-severe, sometimes prolonged pain; deep infection; adjacent nerve and artery damage; and increased risk of stress fracture. Although there may be slight differences between autograft and allograft sources in the postoperative rate of union, clinical studies have demonstrated similar rates of postoperative fusion (90%–100%) and satisfactory outcomes for single-level, anterior-plated ACDF using either bone source. Thus, the choice of graft material involves a trade-off between the risks specific to autograft harvest versus those specific to use of allograft material."

A systematic review of randomized controlled trials found no reliable evidence for use of cages over autograft for cervical spinal fusion (Jacobs et al, 2011).  Noting that the number of surgical techniques for decompression and anterior cervical interbody fusion (ACIF) for cervical degenerative disc disease has increased, the investigators sought to determine which technique of ACIF gives the best outcome.  From a comprehensive search, the investigators selected randomized studies that compared anterior cervical decompression and ACIF techniques, in patients with chronic single- or double-level degenerative disc disease or disc herniation.  Risk of bias was assessed using the criteria of the Cochrane back review group. A total of 33 studies with 2,267 patients were included.  The major treatments were discectomy alone and addition of an ACIF procedure (graft, cement, cage, and plates).  The investigators stated, at best, there was very low-quality evidence of little or no difference in pain relief between the techniques.  The investigators found moderate quality evidence for few secondary outcomes.  The investigators found that Odom's criteria were not different between iliac crest autograft and a metal cage (risk ratio [RR]: 1.11; 95 % confidence interval [CI]: 0.99-1.24).  Bone graft produced more fusion than discectomy (RR: 0.22; 95 % CI: 0.17-0.48).  Complication rates were not different between discectomy and iliac crest autograft (RR: 1.56; 95 % CI: 0.71-3.43).  Low-quality evidence was found that iliac crest autograft results in better fusion than a cage (RR: 1.87; 95 % CI: 1.10-3.17); but more complications (RR: 0.33; 95 % CI: 0.12-0.92).  The investigators concluded that, when fusion of the motion segment is considered to be the working mechanism for pain relief and functional improvement, iliac crest autograft appears to be the gold standard. The investigators stated that, when ignoring fusion rates and looking at complication rates, a cage as a gold standard has a weak evidence base over iliac crest autograft, but not over discectomy.

An evidence review by Epstein et al (2012) reached similar conclusions. Epstein (2012) noted that grafting choices available for performing anterior cervical diskectomy/fusion (ACDF) procedures have become a major concern for spinal surgeons, and their institutions. The "gold standard", iliac crest autograft, may still be the best and least expensive grafting option; it deserves to be reassessed along with the pros, cons, and costs for alternative grafts/spacers. Although single or multilevel ACDF have utilized iliac crest autograft for decades, the implant industry now offers multiple alternative grafting and spacer devices; (allografts, cages, polyether-etherketone (PEEK) amongst others). While most studies have focused on fusion rates and clinical outcomes following ACDF, few have analyzed the "value-added" of these various constructs (e.g. safety/ efficacy, risks/complications, costs). Epstein (2012) found that the majority of studies document 95%-100% fusion rates when iliac crest autograft is utilized to perform single level ACDF (X-ray or CT confirmed at 6-12 postoperative months). Although many allograft studies similarly quote 90%-100% fusion rates (X-ray alone confirmed at 6-12 postoperative months), a recent "post hoc analysis of data from a prospective multicenter trial" (Riew KD et. al., CSRS Abstract Dec. 2011; unpublished) revealed a much higher delayed fusion rate using allografts at one year 55.7%, 2 years 87%, and four years 92%. The author found no clinically significant differences in cervical spine fusion outcomes between autograft and cages, despite an up to 10-fold difference in cost among various constructs. The author concluded that iliac crest autograft utilized for single or multilevel ACDF is associated with the highest fusion, lowest complication rates, and significantly lower costs compared with allograft, cages, PEEK, or other grafts. As spinal surgeons and institutions become more cost conscious, we will have to account for the "value added" of these increasingly expensive graft constructs.

Kersten et al (2015) stated that polyetheretherketone (PEEK) cages have been widely used during the past decade in patients with degenerative disorders of the cervical spine. Their radiolucency and low elastic modulus make them attractive attributes for spinal fusion compared with titanium and bone graft. Still, limitations are seen such as pseudoarthrosis, subsidence, and migration of the cages. The authors stated that limited evidence on the clinical outcome of PEEK cages is found in the literature other than noncomparative cohort studies with only a few randomized controlled trials. The authors conducted a systematic evidence review to assess the clinical and radiographic outcome of PEEK cages in the treatment of degenerative disc disorders and/or spondylolisthesis in the cervical spine. The systematic review included all randomized controlled trials and prospective and retrospective nonrandomized comparative studies with a minimum follow-up of 6 months and all noncomparative cohort studies with a long-term follow-up of more than 5 years. The primary outcome variable was clinical performance. Secondary outcome variables consisted of radiographic scores. The MEDLINE, EMBASE, and Cochrane Library databases were searched according to the Preferred Reporting Items of Systematic reviews and Meta-Analyses statement and Metaanalysis Of Observational Studies in Epidemiology guidelines. A total of 223 studies were identified, of which 10 studies were included. These comprised two randomized controlled trials, five prospective comparative trials, and three retrospective comparative trials. The authors found minimal evidence for better clinical and radiographic outcome for PEEK cages compared with bone grafts in the cervical spine. No differences were found between PEEK, titanium, and carbon fiber cages. The authors stated that future studies are needed to improve methodology to minimize bias. Publication of lumbar interbody fusion studies needs to be promoted because differences in clinical and/or radiographic scores are more likely to be demonstrated in this part of the spine.

The Joint Section on Disorders of the Spine and Peripheral Nerves of the American Association of Neurological Surgeons and Congress of Neurological Surgeons (Ryken et al, 2009) conducted a systematic review to determine the efficacy of cervical interbody grafting techniques. The National Library of Medicine and Cochrane Database were queried using MeSH headings and keywords relevant to cervical interbody grafting. Abstracts were reviewed and studies that met the inclusion criteria were selected. The guidelines group assembled an evidentiary table summarizing the quality of evidence (Classes I-III). Disagreements regarding the level of evidence were resolved through an expert consensus conference. The group formulated recommendations that contained the degree of strength based on the Scottish Intercollegiate Guidelines network. Validation was done through peer review by the Joint Guidelines Committee of the American Association of Neurological Surgeons/Congress of Neurological Surgeons. The authors found that autograft bone harvested from the iliac crest, allograft bone from either cadaveric iliac crest or fibula, or titanium cages and rectangular fusion devices, with or without the use of autologous graft or substitute, have been successful in creating arthrodesis after 1- or 2-level anterior cervical discectomy with fusion (Class II). Alternatives to autograft, allograft, or titanium cages include polyetheretherketone cages and carbon fiber cages (Class III). Polyetheretherketone cages have been used successfully with or without hydroxyapatite for anterior cervical discectomy with fusion. Importantly, recombinant human bone morphogenic protein-2 carries a complication rate of up to 23-27% (especially local edema) compared with 3% for a standard approach. The authors concluded that current evidence does not support the routine use of interbody grafting for cervical arthrodesis. Multiple strategies for interbody grafting have been successful with Class II evidence supporting the use of autograft, allograft, and titanium cages.

The Congress of Neurological Surgeons assessment (Ryken et al, 2009) stated that “class II evidence indicates that either autograft bone harvested from iliac crest, allograft bone from either cadaveric iliac crest or fibula, or titanium cages and rectangular fusion devices, with or without autologous graft or substitute are excellent interbody treatment options for obtaining cervical arthrodesis. There is an expected autograft fusion rate for non-instrumented single-level fusions better than 80% and for 2-level fusion of better than 70%. With allograft, the expected fusion rate for non-instrumented single-level fusion is > 80%, and is > 50% for 2-level fusion. The use of titanium cages carries an expectation of a fusion rate of > 70%, and often > 90% with avoidance of donor site morbidity.” The CNS assessment stated: “In choosing a graft strategy, no single type of graft has not proven consistently superior to the other. Class III evidence suggests that the surgeon consider the increased rate of subsidence with allograft but also understand that subsidence does not correlate with clinical outcome. Class III evidence also suggests that the surgeon factor in the incidence of donor pain and decrease in patient satisfaction reported with the harvest of autograft iliac crest graft.” The assessment stated: “If alternatives to auto- and allograft are preferred, therapeutic options are as follows: PEEK may be considered with or without the use of hydroxyapatite after ACDF. There is an expectation of fusion rates > 90% with fewer complications due to the absence of graft harvesting (Class III). Carbon fiber cages may be considered as well with fusion rates ranging from 55 to 62% in the larger studies (Class III). Polymethyl-methylmethacrylate may be considered to preserve intervertebral distraction after discectomy, but is a poor fusion substrate (Class II). All of the above options appear to have similar clinical outcomes equivalent to the use of bone.” The CNS assessment concluded that, “Given the generally high rates of improved clinical outcome with anterior cervical discectomy and fusion, regardless of methodology, the evaluation of medical-economic factors may play an important role in future studies.”

A Senate Finance Committee Report (2012) focusing on Infuse, one substitute for bone graft, noted that company officials inserted language into studies that promoted the substitute as a better technique than the autograft technique by emphasizing the pain associated with the autograft technique.

Chemonucleolysis

Chemonucleolysis is a procedure that involves the dissolving of the gelatinous cushioning material in an intervertebral disk by the injection of chymopapain or other enzyme.  The AHCPR evidence-based guideline on the management of acute back pain and the medical literature supports the use of chemonucleolysis (CNL) with chymopapain as a safe and effective alternative to surgical disc excision in the majority of patients who are candidates for surgery for intractable sciatica due to herniated nucleus pulposus (HNP).  Chemonucleolysis involves the enzymatic degradation of the nucleus pulposus, and has been shown to be more effective than percutaneous discectomy since it can be successfully performed for protruded and extruded discs, just as long as the herniated disc material is still in continuity with the disc of its origin.  Following CNL, in many cases, relief of sciatica is immediate; however, in up to 30 % of patients, maximal relief of symptoms may take up to 6 weeks.  The overall success rate for CNL in long-term follow-up (7 to 20 years) in 3,130 patients from 13 contributors averaged 77 % (range of 71 to 93 %), the same as that reported for surgical discectomy.  In the United States, CNL is approved by the Food and Drug Administration (FDA) for use in the lumbar spine only.

Facet Joint Blocks and Medial Branch Blocks

Facet injections, also known as facet blocks, are injections of a local anesthetic, with or without a steroid medication, into the facet joints or around the nerve supply (the medial branch nerve) to the joints. Facet injections may be given for diagnostic purposes to determine if the facet joint is the source of pain or it may be performed to treat facet pain that has previously been detected.31 The injections are fluoroscopically guided. If the pain is relieved, the physician will know that the facet joint appears to be the source of pain. This may be followed with therapeutic injections of anti-inflammatory (steroid) and/or local anesthetic medications to relieve pain for longer periods. Facet denervation may also follow a successful diagnostic facet block. 

Degenerative changes in the posterior lumber facet joints have been established as a source of LBP that may radiate to the leg. Pain impulses from the medial branches of lumbar dorsal rami can be interrupted by blocking these nerves with anesthetic (facet block) or coagulating them with a radiofrequency wave (radiofrequency facet denervation).  Typically, facet joint blocks are performed as a part of a work-up for back or neck pain (Wagner, 2003).  Pain relief following a precise injection of local anesthetic confirms the facet joint as the source of pain.  Based on the outcome of a facet joint nerve block, if the patient gets sufficient relief of pain but the pain recurs, denervation of the facet joint may be considered.

A number of uncontrolled studies have suggested positive effects of facet injections on chronic back pain (Wagner, 2003).  However, randomized controlled trials (RCTs) have failed to demonstrated a benefit.  A well-designed trial (n = 101) of patients who responded to a local anesthetic injection into the facet joint published in the New England Journal of Medicine found no difference in the likelihood of pain relief following randomization to glucocorticoid or saline facet joint injection at either 1 or 3 months post injection (Carette et al, 1991).  A higher proportion of patients in the steroid injection group reported marked improvement after 6 months (46 % versus 15 %), but the benefit was attenuated after controlling for co-interventions used in the steroid group, and there is no biologic explanation for a delayed benefit from steroids.  A second, smaller trial found no differences between steroid and/or bupivacaine injection compared to placebo (Lilius et al, 1989).

A number of systematic evidence reviews and evidence-based guidelines have evaluated the literature on facet injections for chronic back pain.  Guidelines from the American Pain Society (Chou et al, 2009) stated: "We found good or fair evidence that ... facet joint injection ... are not effective." Guidelines from the American Association of Neurological Surgeons (Resnick et al, 2005) state: "Facet injections are not recommended as long-term treatment for chronic low-back pain." Guidelines from the American College of Occupational and Environmental Medicine (Hegmann, 2007) state that therapeutic facet joint injections for acute, subacute, chronic low back pain or radicular pain syndrome are "not recommended".  An assessment by the Canadian Agency for Drugs and Technologies in Health (Zakaria et al, 2007) concluded: "According to the RCTs [randomized controlled trials] completed to date, FJIs [facet joint injections] with local anesthetics or steroids have not been proven to be superior to placebo for the treatment of chronic LBP [low back pain]. Steroid FJIs have not been proven to be superior to local anesthetic FJIs in the treatment of chronic neck pain secondary to a motor vehicle accident.  The studies are limited. ..."  An assessment for BMJ Clinical Evidence (McIntosh and Hall, 2007) concluded that facet injections for chronic back pain are of "unknown effectiveness".  A Cochrane systematic evidence review found no clear differences between facet joint glucocorticoid and placebo injections (Staal et al, 2008).  A review in UpToDate (Chou, 2009) stated: "Evidence is unavailable, unreliable, or contradictory regarding the effectiveness of glucocorticoid injections for other sites, including ... facet joint injections .... We suggest not performing these procedures for chronic low back pain".

Sacroiliac Joint Injections

Sacroiliac (SI) joint injections are performed by injecting a local anesthetic, with or without a steroid medication, into the SI joints. These injections may be given for diagnostic purposes to determine if the SI joint is the source of the low back pain or it may be performed to treat SI joint pain that has previously been detected/diagnosed. If the pain is relieved, the physician will know that the SI joint appears to be the source of pain. This may be followed up with therapeutic injections of anti-inflammatory (steroid) and/or local anesthetic medications to relieve pain for longer periods.

In a prospective, single-blinded, randomized controlled trial, Jee and colleagues (2014) compared the safety and short-term effects of ultrasound (US)-guided SIJ injections with fluoroscopy (FL)-guided SIJ injections in patients with non-inflammatory SIJ dysfunction (n = 120).  All procedures were performed using an FL or US apparatus.  Subjects were randomly assigned to either the FL or US group.  Immediately after the SIJ injections, fluoroscopy was applied to verify the correct placement of the injected medication and intravascular injections.  Treatment effects and functional improvement were compared at 2 and 12 weeks after the procedures.  The verbal numeric pain scale and Oswestry Disability Index (ODI) improved at 2 and 12 weeks after the injections without statistical significances between groups.  Of 55 US-guided injections, 48 (87.3 %) were successful and 7 (12.7 %) were missed.  The FL-guided SIJ approach exhibited a greater accuracy (98.2 %) than the US-guided approach.  Vascularization around the SIJ was seen in 34 of 55 patients.  Among the 34 patients, 7 had vascularization inside the joint, 23 had vascularization around the joint, and 4 had vascularization both inside and around the joint; 3 cases of intravascular injections occurred in the FL group.  The authors concluded that the US-guided approach may facilitate the identification and avoidance of the critical vessels around or within the SIJ.  Function and pain relief significantly improved in both groups without significant differences between groups.  The US-guided approach was shown to be as effective as the FL-guided approach in treatment effects.  However, diagnostic application in the SIJ may be limited because of the significantly lower accuracy rate (87.3 %).

Radiofrequency Facet Denervation

Radiofrequency ablation (may also be referred to as RFA, percutaneous radiofrequency neuroablation, radiofrequency coagulation, radiofrequency denervation, radiofrequency lesioning, radiofrequency neuroablation, radiofrequency neurotomy or rhizotomy [articular rhizolysis]) involves the use of radiofrequency energy to denervate a nerve. One of the most commonly performed neuroablative procedures is facet denervation, which is the destruction or interruption of a facet joint nerve to relieve chronic pain in the cervical, thoracic or lumbar region of the spine.

Facet joints of the spine have joint capsules that are supplied by a branch of the posterior ramus of the spinal nerve.  Percutaneous radiofrequency facet denervation, also known as radiofrequency facet joint rhizotomy or facet neurotomy, involves selective denervation using radiofrequency under fluoroscopic guidance.  As a method of neurolysis, radiofrequency facet denervation has been shown to be a very safe procedure and can offer relief for many patients with mechanical LBP in whom organic pathology, most commonly a herniated lumbar disc, has been eliminated.  According to the literature, it offers advantages over conventional neurolytic agents (e.g., phenol, alcohol, and hypertonic saline) because of its long lasting effects, the relative lack of discomfort, and its completely local action without any random diffusion of the neurolytic agent.  Because there are no reliable clinical signs that confirm the diagnosis, successful relief of pain by injections of an anesthetic agent into the joints are necessary before proceeding with radiofrequency facet denervation.  Results from many studies have shown that radiofrequency facet denervation results in significant (excellent or good) pain relief, reduced use of pain medication, increased return-to-work, and is associated with few complications.  Success rate, however, depends on a careful selection of patients.

Laser Facet Denervation

Neuroablative techniques in pain management consist of several surgical and non-surgical methods to denervate a nerve. The goal of denervation is to "shut off" the pain signals that are sent to the brain from the joints and nerves. An additional objective is to reduce the likelihood of, or to delay, any recurrence by selectively destroying pain fibers without causing excessive sensory loss, motor dysfunction or other complications.

Laser ablation involves the use of laser to denervate a nerve. There is a lack of published evidence of laser facet denervation for lumbar facet pain.

Facet Chemodenervation/Chemical Facet Neurolysis

Chemical neurolysis (also referred to as chemical ablation, chemical denervation or chemodenervation) involves injection of neurolytic agents [eg, phenol, alcohol or hypertonic saline]) to denervate a nerve. The use of chemical facet injections such as alcohol, phenol and hypertonic saline has been proposed as an option for lumbar facet pain.  However, there is a lack of published data to support the safety and effectiveness of this technique. 

Pedicle Screw Fixation

Pedicle screw fixation systems consist of steel or titanium plates that are longitudinally inter-connected and anchored to adjacent vertebrae using bolts, hooks, or screws.  Pedicle screw fixation in the spine is used to produce a rigid connection between 2 or more adjacent vertebrae in order to correct deformity and to stabilize the spine, thereby reducing pain and any neurological deficits.  It is most often used in the lumbosacral spine from L1 though S1, and may also be used in the thoracic spine.  Excision of tissues compressing the spinal cord (posterior decompression) is a common treatment for patients with herniated or subluxed vertebrae (spondylolisthesis), degenerative intervertebral discs, certain types of vertebral fractures, or spinal tumors.  Spinal instability following decompression may be sufficiently severe to require stabilization by bony fusion (arthrodesis) of affected and adjacent vertebrae using implanted autologous bone grafts.  Following placement of the graft, sufficient mechanical stability to allow its incorporation may be provided by combinations of various surgically implanted hooks, rods, or wires.  However, severe instability may require surgical implantation of plates or rods anchored to vertebral pedicles using screws (pedicle screw fixation systems) in order to provide rigid 3-column fixation and minimize the risk of incomplete fusion (pseudoarthrosis or pseudarthrosis) or loss of alignment during fusion.  The current medical literature suggests that rigid fixation of the lumbar spine with pedicle screws improves the chances of successful fusion as compared with patients with lumbar spine fusion not supplemented with internal fixation.  Internal fusion and fixation are major operative procedures with significant risks and according to the available literature should be reserved for patients with spinal instability associated with neurological deficits, major spinal deformities, spinal fracture, spinal dislocation or complications of tumor.  Spinal fusion and pedicle screw fixation has been shown not to be effective for the treatment of isolated chronic back pain, and surgery is not advocated to treat this diagnosis in the absence of instability or neurological deficits.  In July 1998, the FDA re-classified into Class II the pedicle screw spinal systems intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute or chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).  Pedicle screw systems intended for any other uses are considered post-amendment Class III devices for which pre-market approval is required.

Intervertebral Body Fusion Devices (Spine Cages)

A spine cage, also known as an interbody cage, is a small hollow cylindrical device, usually made of titanium, with perforated walls.  The device is placed in the disc space between 2 vertebrae to restore lost disc height resulting from a collapsed disc and to relieve pressure on nerve roots.  Currently, there are 2 intervertebral body fusion devices approved by the FDA: the BAK Interbody Fusion System (Spine-Tech, Inc.), and the Ray Threaded Fusion Cage (Surgical Dynamics, a subsidiary of United States Surgical Corporation).  The BAK (Bagley and Kuslich) Interbody Fusion System and the Ray Threaded Fusion Cage (TFC) are hollow cylinders made of titanium, which may be implanted by anterior or posterior approach.  Unlike pedicle screws, both of these fusion devices are permanent implants, as the literature describes bone growing into and through the implant.  The safety and effectiveness of these fusion devices have not been established in 3 or more levels to be fused, previous fusion attempt at the involved level(s), spondylolisthesis or retrolisthesis of Grade II or greater.  Although the BAK has received FDA approval for implantation laparoscopically, studies performed for FDA approval demonstrated significantly greater incidence of complications from anterior spinal reconstructive surgery using a laparoscopic approach than using an open approach.  Furthermore, patients with laparoscopically implanted BAK fusion devices were followed for only 6 months; thus, the long-term stability of laparoscopically implanted BAK cages is unknown.  Thus, coverage of laparoscopic (endoscopic) implantation of the BAK should be denied as experimental and investigational.  (See discussion of anterior endoscopic spinal reconstructive surgery above).

Vertebroplasty

Percutaneous polymethylmethacrylate vertebroplasty (PPV) is a therapeutic, interventional radiologic procedure, which consists of the injection of an acrylic bone cement (usually methyl methacrylate) into a cervical, thoracic or lumbar vertebral body lesion for the relief of pain and the strengthening of bone. The procedure is performed under fluoroscopic guidance with local anesthesia and moderate sedation. This procedure is being used for patients with lytic lesions due to bone metastases, aggressive hemangiomas, or multiple myeloma, and for patients who have medically intractable debilitating pain resulting from osteoporotic vertebral collapse.   

Examples of PMMA include, but may not be limited to, Ascendx Cement, Cobalt HV, Cobalt V Radiopaque Vertebroplasty Bone Cement, Cohesion, Kyphx HV-R, Opacity+, Osteopal, Osteopal V, SPACE CpsXL, Spine-Fix Biomimetic Bone Cement, StabiliT ER, Vertecern and Vertefix Radiopaque Bone Cement. An alternative to traditional bone cement is Cortoss Bone Augmentation Material. Cortoss is an injectable, non-resorbable synthetic material that functions as a strengthening agent for injection into vertebral bodies with compression fractures. 

Results from two uncontrolled prospective studies and several case series reports, including one with 187 patients, indicated that percutaneous vertebroplasty can produce significant pain relief and increase mobility in 70 % to 80 % of patients with osteolytic lesions in the vertebrae.  In these reports, pain relief was apparent within 1 to 2 days after injection, and appeared to persist for at least several months up to several years.  While experimental studies and preliminary clinical results suggest that percutaneous vertebroplasty can also strengthen the vertebral bodies and increase mobility, it remains to be proven whether this procedure can prevent additional fractures in the injected vertebrae.  In addition, the duration of effect was not known; there were no long-term follow-up data on most of these patients, and these data may be difficult to obtain and interpret in patients with an underlying malignant process because disease progression may confound evaluation of the treatment effect.  Complications were relatively rare, although some studies reported a high incidence of clinically insignificant leakage of bone cement into the paravertebral tissues.  In a few cases, the leakage of polymer caused compression of spinal nerve roots or neuralgia.  Several instances of pulmonary embolism were also reported.

The FDA (2004) notified healthcare professionals about complications related to the use of polymethylmethacrylate bone cement to treat osteoporotic compression fractures of the spine using vertebroplasty and kyphoplasty.  Reported complications, such as soft tissue damage and nerve root pain and compression, are related specifically to the leakage of bone cement.  Other reported complications include pulmonary embolism, respiratory and cardiac failure, and death.

Percutaneous vertebroplasty is an in-patient procedure because it may cause compression of adjacent structures and require emergency decompressive surgery.  In addition, radiation therapy or concurrent surgical interventions, such as laminectomy, may also be required in patients with compression of the spinal cord due to ingrowth of a tumor.  An assessment of percutaneous vertebroplasty by the National Institute for Clinical Excellence (NICE, 2003) concluded that "current evidence on the safety and efficacy of percutaneous vertebroplasty appears adequate".

However, 2 subsequently published RCTs published in the New England Journal of Medicine have found no significant benefit with vertebroplasty.  In the Investigational Vertebroplasty Safety and Efficacy Trial (INVEST), Kallmes et al (2009) reported that pain and disability outcomes at 1 month in a group of patients who underwent vertebroplasty were similar to those in a control group that underwent a sham procedure.  In the other trial, Buchbinder et al (2009) measured pain, quality of life, and functional status at 1 week and at 1, 3, and 6 months after sham and active vertebroplasty and found there were no significant between-group differences at any time point.  As in INVEST, patients in the 2 study groups had improvement in pain.

The Society for Interventional Radiology (SIR, 2009) had identified a number of issues in interpreting these studies, including potential biases in patient selection, the use of vertebroplasty in older (greater than 3 months) fractures, and a potentially inadequate amount of polymethylmethacrylate (PMMA) that was injected into the vertebrae.  The SIR concluded: "We recognize the value of randomized controlled trials and evidence-based medicine.  But based on the above-discussed weakness in the studies and the degree of discordance between the outcomes of these studies, prior studies and experience, we believe it is premature -- and possibly incorrect -- to conclude that vertebroplasty is no better than a control sham procedure (trigger point, facet injection).  We suggest waiting for the results of the VERTOSS 2 trial to be published and encourage larger clinical trials to address the weaknesses of the two New England Journal of Medicine articles".

In a retrospective study, He and colleagues (2008) examined if a repeat percutaneous vertebroplasty (PV) is effective on pain-relief at the vertebral levels in patients who had previously undergone PV.  Of the 334 procedures of PV performed in 242 patients with osteoporotic vertebral compression fractures from October 2000 to June 2006 in the authors' institute, 15 vertebrae in 15 patients with unrelieved pain in 4 to 32 days after an initial PV were treated with a repeat vertebroplasty.  The clinical outcomes were assessed by measurements of visual analog scale (VAS), and the imaging features were analyzed pre- and post-procedure.  The mean volume of polymethylmethacrylate injected in each vertebra was 4.0 ml (range of 1.5 to 9 ml) in the repeat PV.  During the first month of follow-up after repeat PV in this series, a mean VAS scores of the pain level was reduced from 8.6 (range of 7 to 10) pre-procedure to 1.67 points (range of 0 to 4) post-procedure, with a mean reduction of 6.93 points (range of 4 to 8).  Complete and partial pain relief were reached in 11 (73 %) and 4 patients (27 %), respectively in a mean follow-up of 15 months.  No serious complications related to the procedures occurred, however asymptomatic polymethylmethacrylate leakage around vertebrae was demonstrated on radiograph or computed tomography in 2 patients.  The authors concluded that the outcomes of this series suggested that repeat PV is effective at the same vertebral levels in patients without pain-relief who underwent previous PV.  Absent or inadequate filling of cement in the unstable fractured areas of the vertebral body may be responsible for the unrelieved pain after the initial PV.

An accompanying editorial by Kallmes (2008) of the afore-mentioned article stated that "[u]nfortunately, limitations in the current study likely preclude definitive answers, but still the series may help focus future studies".  The editorialist also noted that while the authors found insufficient or absent filling in 100 % of the failed cases, they did not provide any information regarding the frequency in which they had insufficient or absent filling in the other 227 (successful) cases.  Furthermore, Kallmes is still somewhat concerned about the safety of the repeat procedure.

Absolute contraindications to percutaneous vertebroplasty or kyphoplasty (balloon-assisted vertebroplasty) include, but may not be limited to, the following:

  • Allergy to bone cement or contrast media; or
  • Asymptomatic vertebral compression fractures; or
  • Individual is improving with medical therapy; or
  • Nonfractured vertebral levels; or
  • Ongoing local or systemic infection; or
  • Osteomyelitis of the target vertebra; or
  • Prophylactic treatment for osteoporosis to prevent future fractures; or
  • Retropulsed bone fragment resulting in myelopathy; or
  • Spinal canal compromise secondary to tumor resulting in myelopathy; or
  • Uncorrected coagulation disorders.

Relative contraindications to percutaneous vertebroplasty include, but may not be limited to, the following:

  • Asymptomatic retropulsion of a fracture fragment causing significant spinal compromise; or
  • Asymptomatic tumor extension into the epidural space; or
  • Radiculopathy in excess of vertebral pain, caused by a compressive syndrome unrelated to vertebral collapse.

Kyphoplasty

Kyphoplasty (also known as balloon-assisted vertebroplasty) is a minimally-invasive orthopedic procedure, which has been developed to restore bone height lost due to painful osteoporotic compression fractures. It is a modification of the vertebroplasty procedure, and involves the insertion of 1 or 2 balloon devices into the fractured vertebral body.  Once inserted, the surgeon inflates the balloon(s) to create a cavity and to compact the deteriorated bone with the intent to restore vertebral height.  The balloon(s) are then removed and the newly created cavity is filled with the surgeon's choice of bone filler material, creating an internal cast for the fractured area.

The Kiva VCF Treatment System is an implantable device which has been proposed for use with a vertebroplasty or kyphoplasty procedure for reduction and treatment of spinal fractures. PMMA bone cement is used to fill the implant once it is placed.

An assessment of balloon kyphoplasty by the National Institute for Health and Clinical Excellence (NICE, 2006) concluded that "[c]urrent evidence on the safety and efficacy of balloon kyphoplasty for vertebral compression fractures appears adequate to support the use of this procedure provided that normal arrangements are in place for consent, audit and clinical governance".  The NICE assessment reviewed 3 non-randomized studies, 2 of which compared balloon kyphoplasty with conventional medical care (physical and analgesic therapy) and 1 which compared the procedure with vertebroplasty.  All 3 studies found that patients who had undergone balloon kyphoplasty had improved pain scores compared with the control group at a maximum follow-up of 24 months.  The assessment noted that the specialist advisors to NICE expressed uncertainties about whether the improvements following balloon kyphoplasty (reduced pain and height restoration) are maintained in the long term.  In clinical studies, the most common complication following balloon kyphoplasty was cement leakage, occurring in up to 11 % of patients.  Other potential complications of kyphoplasty include infection, allergy, and spinal cord or nerve root injury caused by incorrect needle placement.

Based on the results of an assessment, the Ontario Ministry of Health and Long Term Care (2004) reached the following conclusions about balloon kyphoplasty: "There are currently two methods of cement injection for the treatment of osteoporotic VCFs.  These are vertebroplasty and balloon kyphoplasty.  Although no RCT has been conducted to compare the two techniques, the existing evidence shows that balloon kyphoplasty is a reasonable alternative to vertebroplasty, given the lower reported peri-operative and long-term complications of balloon kyphoplasty".

Wardlaw et al (2009) reported positive results with kyphoplasty compared with non-surgical care in a non-blinded, multi-center RCT.  The investigators randomly assigned 300 adults with 1 to 3 acute vertebral fractures to kyphoplasty (n = 149) or non-surgical care (n = 151).  At 1 month, mean SF-36 Physical Component Score (PCS) improved by 7.2 points (95 % confidence interval  [CI]: 5.7 to 8.8) in the kyphoplasty group, and by 2.0 points (95 % CI: 0.4 to 3.6) in the non-surgical group, a difference between groups that was statistically significant (p < 0.0001).  The investigators reported that the frequency of adverse events did not differ between groups.  There were 2 serious adverse events related to kyphoplasty (hematoma and urinary tract infection); other serious adverse events (such as myocardial infarction and pulmonary embolism) did not occur peri-operatively and were not related to procedure.

The California Technology Assessment Forum (Karliner, 2009) concluded that balloon kyphoplasty meets CTAF criteria for safety, effectiveness and improvement in health outcomes for the treatment of recent (less than 3 month old) osteoporotic vertebral compression fractures confirmed by MRI.

Sacroplasty

Sacroplasty is a variation of the vertebroplasty technique, and involves the injection of polymethylmethacrylate cement into sacral insufficiency fractures for stabilization. Under fluoroscopic guidance, PMMA is injected into the sacrum at the fracture site, in an attempt to stabilize the fracture. Sacral insufficiency fractures (SIFs) can cause LBP in osteoporotic patients.  Symptomatic improvement may require up to 12 months.  Treatment includes limited weight-bearing and bed rest, oral analgesics, and sacral corsets.  Significant mortality and morbidity are associated with pelvic insufficiency fractures.  Percutaneous sacroplasty is being developed as an alternative treatment for SIF patients.

Frey et al (2007) reported on a prospective observational cohort study of the safety and efficacy of sacroplasty in consecutive osteoporotic patients with SIFs.  Each procedure was performed under intravenous conscious sedation using fluoroscopy.  Two bone trochars were inserted between the sacral foramen and sacroiliac joint through which 2 to 3 ml of polymethylmethacrylate was injected.  A total of 37 patients, 27 females, were treated.  Mean age was 76.6 years, and mean symptom duration was 34.4 days.  All patients were available at each follow-up interval except 1 patient who died due to unrelated pulmonary disease before the 4-week follow-up.  The investigators reported that mean VAS score at baseline was 7.7 and 3.2 within 30 mins, and 2.1 at 2, 1.7 at 4, 1.3 at 12, 1.0 at 24, and 0.7 at 52 weeks post-procedure.  The investigators found that improvement at each interval and overall was statistically significant using the Wilcoxon Rank Sum Test.  One case of transient S1 radiculitis was encountered.  The investigators concluded that sacroplasty appears to be a safe and effective treatment for painful SIF.  Limitations of this study include its small size, limited duration of follow-up, and lack of control group.

Vesselplasty

Vesselplasty (Vessel-X, A-Spine Holding Group Corp., Taipei, Taiwan) is an image-guided procedure that attempts to solve the problem of cement leakage out of the vertebral body, which can happen during both vertebroplasty and kyphoplasty.  Cement leakage, a common problem with vertebroplasty particularly in lytic lesions (Mathis and Wong, 2003), has been reported in up to 30 % to 70 % of cases.  Most occurrences, however, are asymptomatic (Cortet et al, 1997).  Vesselplasty uses a porous polyethylene terephthalate balloon to create both a cavity and contain the cement, thereby, allowing only a small amount of cement to permeate into the vertebral body.

Flors et al (2009) evaluated the use of vesselplasty to treat symptomatic vertebral compression fractures (VCFs) in 29 patients.  All patients had been undergoing medical therapy for 1 or more painful VCFs.  Pain, mobility, and analgesic use scores were obtained, and restoration of vertebral body height was evaluated.  A 2-tailed paired Student's t test was used to compare differences in the mean scores for levels of pain, mobility, and analgesic use before and after the procedure and to evaluate changes in vertebral body height.  Seven of the 29 patients had fractures in more than 1 level, for a total of 37 procedures.  The cause of the vertebral collapse was osteoporosis in 27 (73 %), high-impact trauma in 5 (13.5 %), myeloma in 3 (8 %), and metastatic fracture in 2 (5.4 %).  The average pain score before treatment was 8.72 +/- 1.25 (SD), whereas the average pain score after treatment was 3.38 +/- 2.35.  The average mobility score before treatment was 2.31 +/- 1.94, whereas the average mobility score after treatment was 0.59 +/- 1.05 (p < 0.001).  The average analgesic use score before treatment was 3.07 +/- 1.46, whereas it was 1.86 +/- 1.90 after treatment (p < 0.001).  There was no evidence of clinical complications.  The authors concluded that vesselplasty offers statistically significant benefits in improvements of pain, mobility, and the need for analgesia in patients with symptomatic VCFs, thus providing a safe alternative in the treatment of these fractures.

While vesselplasty appears to be a promising new technique for VCFs, there is insufficient evidence of its safety and effectiveness.  Prospective, randomized, controlled studies with a larger number of patients and long-term follow-up are needed.

Epiduroscopy

Epiduroscopy involves insertion of a fiberoptic camera through the sacral hiatus into the lower epidural space, which is then guided upwards towards the lower lumbar discs and nerve roots.  Epidural adhesions can be released and anesthetic and steroid injected around nerve roots.  In September 1996, the epiduroscope (myeloscope) was cleared by the FDA for visualization of the epidural space.  It has been used in the outpatient setting for the diagnosis and treatment of intractable LBP.  Insertion of this miniature fiberoptic scope into the epidural space allows direct visualization of scarring and placement of a catheter through which fluid is injected under pressure to break down scar tissue and lyse adhesions.  Although a number of pain treatment centers advertise the availability of this technique and claim it to be successful, there is insufficient scientific evidence in the peer-reviewed medical literature to support the clinical utility of this technique for diagnosis or therapy in patients with spinal pain syndromes, including those with failed back surgery syndromes.  Moreover, currently available non-invasive technologies allow adequate visualization of the epidural space to confirm pathology contained therein. An assessment of epiduroscopy for the Australian Safety and Efficacy Register of New Interventional Procedures (ASERNIP-S, 2003) concluded that "[t]here is little high-quality evidence available on the safety and efficacy of epiduroscopically guided surgery/drug delivery... More studies are needed to compare the safety and efficacy of epiduroscopy relative to other procedures".  An assessment by the National Institute for Clinical Excellence (NICE, 2004) concluded that "current evidence on the safety and efficacy of endoscopic epidural procedures does not appear adequate for these procedures to be used without special arrangements for consent and for audit or research." The NICE assessment found that "The studies identified were small and uncontrolled. Some measures used in these studies to assess outcomes, such as scores of pain and function, were of unknown validity".

Epidural Lysis of Adhesions

Epidural lysis of adhesions is a pain management procedure that has been proposed as a method to relieve chronic back pain. This procedure may also be known as adhesiolysis, endoscopic adhesiolysis, epidurolysis, percutaneous adhesiolysis or percutaneous epidural neuroplasty. It differs from epidural injections as it attempts to treat the neural (nerve) adhesions that cause the pain. Epidural lysis of adhesions can be performed by use of a fiberoptic endoscope (epiduroscopy), percutaneously with the use of a catheter (flexible tube) or with the more specialized Racz catheter.

In epiduroscopy, normal saline is injected into the sacral canal to distend and decompress the epidural space; purportedly the fiberoptic endoscope can then directly disrupt the fibrosis, scar tissue or adhesions. This procedure is generally an outpatient procedure utilizing local anesthesia and light sedation.

In the percutaneous procedure utilizing the Racz catheter, the specialized epidural catheter is inserted under fluoroscopy via the sacral canal. The injection of dye (an epidurogram) may indicate the area of adhesions and provide a way to perform lesion-specific lysis utilizing the flexible wire embedded catheter. Local anesthetic, corticosteroid and hypertonic sodium chloride solution injections via the catheter are performed daily for three days. During this time the catheter is left in place and the individual is generally hospitalized.

A similar version of the procedure involves a single use catheter (instead of the Racz catheter) which is removed after the lysis is completed. The procedure may be repeated at a later date, but would require a new catheter placement.