BlueCross BlueShield of Tennessee Medical Policy Manual

Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers); Interspinous Fixation (Fusion) Devices

DESCRIPTION

Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers)

Interspinous spacers are devices implanted between vertebral spinous processes. Interlaminar spacers are implanted between adjacent lamina and have 2 sets of wings that are placed around the inferior and superior spinous processes. The aim of these implants is to restrict painful motion while otherwise enabling normal motion.

In theory, these procedures enlarge the neural foramen and decompress the cauda equina in individuals with spinal stenosis and neurogenic claudication (pain, weakness, cramping and discomfort in the legs that can make it hard to walk). The surgery does not include any laminotomy, laminectomy, or foraminotomy at the time of insertion, thus reducing the risk of epidural scarring and cerebrospinal fluid leakage.

The X-STOP® Interspinous Process Decompression (IPD®) System, Coflex® Interlaminar Technology implant, Superion InterSpinous Spacer, and others have received clearance for marketing by the U.S. Food and Drug Administration (FDA).

Interspinous Fixation (Fusion) Devices

Interspinous fixation (fusion) devices are being developed to aid in the stabilization of the spine. They are being evaluated as alternatives to pedicle screw and rod constructs in combination with interbody fusion. These devices differ from interspinous process spacer devices in that they are used for fixation rather than for motion preservation.

Use of an interspinous fixation (fusion) device in combination with a unilateral pedicle screw system has also been proposed. For use in combination with fusion, interspinous fixation systems are less invasive and present fewer risks than pedicle (the segment between the transverse process and the vertebral body) or facet screws. However, while biomechanical studies indicate that interspinous fixation devices may be similar to pedicle screw-rod constructs in limiting the range of flexion-extension, they may be less effective than bilateral pedicle screw-rod fixation for limiting axial rotation and lateral bending. There is a potential for a negative impact on the interbody cage and bone graft due to focal kyphosis resulting from the interspinous device. There is also a potential for spinous process fracture. Given these uncertainties, studies are needed that compare health outcomes between interspinous fixation devices and pedicle screw-rod fixation.

The following are examples of interspinous fixation devices that have received clearance to market by the U.S. Food and Drug Administration (FDA):

Device (Manufacturer)

  • Affix™ (NuVasive)

  • Axle™ (X-Spine)

  • BacFuse® (Pioneer Surgical)

  • BridgePoint™ (Alphatec)

  • Coflex-F® (Paradigm Spine)

  • Inspan™ (Spine Frontier)

  • Lanx® SFS (Lanx, LLC)

  • PrimaLOK™ (OsteoMed)

  • SP-Fix™ (Globus)

  • Spire™ (Medtronic)

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION 

Interspinous and interlaminar implants (spacers) stabilize or distract the adjacent lamina and/or spinous processes and restrict extension to reduce pain in patients with lumbar spinal stenosis and neurogenic claudication. Although the randomized device trials report short-term improvements in symptoms and functional status when compared with nonoperative therapy, a number of questions remain. Overall, high quality comparative data are limited. There is a need for longer-term (>2 years) outcome data on symptom relief, the need for repeat procedures, and implant survival; therefore these devices remain investigational.

Randomized controlled trials are needed that evaluate health outcomes following use of interspinous fixation (fusion) devices in comparison with the established standard of pedicle screw-rod fixation. Clinical trials are also needed to evaluate these devices when used alone for decompression. Because of the lack of evidence and the lack of consensus from clinical vetting, interspinous fixation devices are considered investigational.

SOURCES

Bae, H., Lauryssen, C., Maislin, G., Leary, S., & Musacchio, Jr., M. (2015). Therapeutic sustainability and durability of Coflex interlaminar stabilization after decompression for lumbar spinal stenosis: a four year assessment. International Journal of Spine Surgery, 9 (15), 1-8. (Level 4 evidence - Industry sponsored)

BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2017). Interspinous and interlaminar stabilization/distraction devices (spacers) (7.01.107). Retrieved October 24, 2017 from BlueWeb. (22 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2017). Interspinous fixation (fusion) devices (7.01.138). Retrieved October 24, 2017 from BlueWeb. (6 articles and/or guidelines reviewed)

BlueCross BlueShield of Tennessee network physicians (i.e., Tennessee Orthopedic Society representatives). January 2013.

Cahaba Government Benefits Administratores®, LLC. (2017, February). Local Coverage Determination. (LCD): Surgery: Fusion for Degenerative Joint Disease of the Lumbar Spine (L35942) Retrieved October 24, 2017 from https://www.cms.gov.

Ghany, A., Amer, A., Saeed, K., Emara, E., Hamad, A., Nosseir, M. (2016). Evaluation of interspinous spacer outcomes in degenerative lumbar canal stenosis: clinical study. World Neurosurgery, Epub ahead of print. Abstract retrieved November 18, 2016 from PubMed database.

Ghogawala, Z., Dziura, J., Butler, W., Dai, F., Terrin, N., Magge, S., et al. (2016, April) Laminectomy plus fusion versus laminectomy alone for lumbar spondylolisthesis. The New England Journal of Medicine, 374 (15), 1424-1432. (Level 2 evidence)

Kim, D. H., Shanti, N., Tantorski, M.E., Shaw, J. D., Li, L., Martha, J. F., et al. (2012). Association between degenerative spondylolisthesis and spinous process fracture after interspinous process spacer surgery. The Spine Journal, 12 (6), 466-472. (Level 3 evidence - Industry sponsored)

Lopez, A., Scheer, J., Dahdaleh, N., Patel, A., and Smith, Z. (2017, November) Lumbar spinous process fixation and fusion: a systematic review and critical analysis of an emerging spinal technology. Clinical Spine Surgery, 30 (9), 1279-1288. Abstract retrieved October 23, 2017 from PubMed database.

Machado, G. C., Ferreira, P. H., Harris, I. A., Pinheiro, M. B., Koes, B. W., van Tulder, M., et al. (2015). Effectiveness of surgery for lumbar spinal stenosis: A systematic review and meta-analysis. PLoS One, 10 (3), e0122800. (Level 4 evidence - Independent)

Moojen. W.A., et al. (2013). Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: randomized controlled trial. British Medical Journal, 347: f6415, doi: 10.1136. (Level 2 evidence - Industry sponsored)

National Institute for Health and Clinical Excellence (NICE). (2010, November). Interspinous distraction procedures for lumbar spinal stenosis causing neurogenic claudication. Retrieved November 12, 2014 from http://www.nice.org.uk.

North American Spine Society. (2011). Evidence-based clinical guidelines for multidisciplinary spine care: Diagnosis and treatment of degenerative lumbar spinal stenosis. Retrieved February 3, 2016 from http://www.spine.org/Documents/NASSCG_Stenosis.pdf.   

North American Spine Society. (2014). Evidence-based clinical guidelines for multidisciplinary spine care: Diagnosis and treatment of degenerative lumbar spondylolisthesis, 2nd ed. Retrieved February 3, 2016 from http://www.spine.org/Documents/Spondylolisthesis_Clinical_Guideline.pdf.

Phan, K., Rao, P. J., Ball, J. R., & Mobbs, R. J. (2016). Interspinous process spacers versus traditional decompression for lumbar spinal stenosis: systematic review and meta-analysis. Journal of Spine Surgery, 2 (1), 31-40. (Level 4 evidence - Independent)

U. S. Food and Drug Administration. (2010, August). Center for Devices and Radiological Health. 510(k) Pre-market Notification Database. K100354 (PrimaLOK®). Retrieved November 17, 2016 from http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2010, September). Center for Devices and Radiological Health. Pre-market Notification Database. K103205 (BridgePoint™). Retrieved February 3, 2016 from http://www.accessdata.fda.gov. 

U. S. Food and Drug Administration. (2013, July). Center for Devices and Radiological Health. 510(k) Pre-market Notification Database. K131238 (Affix®). Retrieved November 17, 2016 from http://www.accessdata.fda.gov. 

Verhoff, O. J., Bron, J. L., Wapstra, F. H., & van Royen, B. J., (2008). High failure rate of the interspinous distraction device (X-Stop) for the treatment of lumbar spinal stenosis caused by degenerative spondylolisthesis. European Spine Journal, 17 (2), 188-192. (Level 4 evidence - Independent)

Wu, A. M., Zhou, Y., Li, Q. L., Wu, X. L., Jin, Y. L., Luo, P., et al. (2014). Interspinous spacer versus traditional decompressive surgery for lumbar spinal stenosis: a systematic review and meta-analysis. PloS One, 9 (5), e97142. (Level 3 evidence - Independent)

ORIGINAL EFFECTIVE DATE:  6/8/2013

MOST RECENT REVIEW DATE:  12/14/2017

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