Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers); Interspinous Fixation (Fusion) Devices
Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers)
Interspinous and interlaminar implants (spacers) are proposed to stabilize or distract the adjacent lamina and/or spinous processes and restrict extension to reduce pain in individuals with lumbar spinal stenosis and neurogenic claudication. Interspinous spacers are small devices implanted between the vertebral spinous processes. Interlaminar spacers are implanted between adjacent lamina and spinous processes purportedly to provide dynamic stabilization either following decompressive surgery or as an alternative to decompressive surgery. The Coflex® Interlaminar Technology implant and the Superion InterSpinous Spacer 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. These devices 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.
The following are examples of interspinous fixation devices that have received clearance to market by the U.S. Food and Drug Administration (FDA):
Use of interspinous stabilization/distraction devices (spacers) for all indications, including, but not limited to, use as a treatment for neurogenic intermittent claudication is considered investigational.
Use of interlaminar stabilization/distraction devices (spacers) for all indications, including, but not limited to, use following decompressive surgery is considered investigational.
Use of interspinous fixation (fusion) devices for all indications, including, but not limited to, use in combination with interbody fusion or alone for decompression in individuals with spinal stenosis, is considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
High quality comparative data are limited. Evidence is insufficient to determine the effects of this technology on health outcomes.
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)
BlueCross BlueShield Association. Evidence Positioning System. (4:2017). Interspinous and interlaminar stabilization/distraction devices (spacers) (7.01.107). Retrieved October 18, 2018 from https://www.evidencepositioningsytem.com/ (22 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Evidence Positioning System. (4:2018). Interspinous fixation (fusion) devices (7.01.138). Retrieved October 18, 2018 from BlueWeb. (6 articles and/or guidelines reviewed)
BlueCross BlueShield of Tennessee network physicians (i.e., Tennessee Orthopedic Society representatives). January 2013.
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). 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)
Lopez, A., Scheer, J., Dahdaleh, N., Patel, A., & Smith, Z. (2017). 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)
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)
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)
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.
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)
ORIGINAL EFFECTIVE DATE: 6/8/2013
MOST RECENT REVIEW DATE: 12/13/2018
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