Facet Arthroplasty
DESCRIPTION
Facet arthroplasty refers to the implantation of a spinal prosthesis to restore posterior element structure and function as an adjunct to neural decompression. This procedure is proposed as an alternative to posterior spinal fusion for patients with facet arthrosis, spinal stenosis, and spondylolisthesis.
No facet arthroplasty devices have been approved by the U.S. Food and Drug Administration (FDA) at this time. The Total Facet Arthroplasty System® (TFAS®, Archus Orthopedics) is currently being evaluated as part of an ongoing FDA-approved investigational device exemption (IDE) protocol (Facet Solutions (Hopkinton, MA) acquired Archus Orthopedics and all of their assets in November 2009. Facet Solutions is developing the ACADIA™ Facet Replacement System.). Another implant design, the Total Posterior-element System (TOPS™, Impliant Ltd., Israel), is currently in development.
POLICY
Total facet arthroplasty for the treatment of degenerative disc disease is considered investigational.
See also:
IMPORTANT REMINDER
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.
ADDITIONAL INFORMATION
The lack of well-designed randomized controlled trials and studies provide little evidence of the safety and efficacy to support the use of this technology. Clinical trials regarding these devices have not been verified since 2009.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (7:2010). Facet arthroplasty (7.01.120). Retrieved June 22, 2011 from BlueWeb. (1 article and/or guideline reviewed)
ECRI Institute. Health Technology Information Service. Forecast. Facet replacement devices for lumbar spinal stenosis. Retrieved June 22, 2011 from ECRI Institute. (18 articles and/or guidelines reviewed).
Phillips, F. M., Tzermiadianos, M. N., Voronov, L. I., Havey, R. M., Carandang, G., Renner, S. M., et al. (2008). Effect of the Total Facet Arthroplasty System after complete laminectomy-facetectomy on the biomechanics of implanted and adjacent segments. The Spine Journal, 9 (1), 96-102. (Level 4 Evidence - Industry sponsored)
Zhu, Q., Larson, C. R., Siovold, S. G., Rosler, D. M., Keynan, O., Wilson, D. R., et al. (2007). Biomechanical evaluation of the Total Facet Arthroplasty System: 3-dimensional kinematics. Spine, 32 (1), 55-62. (Level 4 Evidence - Industry sponsored)
ORIGINAL EFFECTIVE DATE: 1/9/2010
MOST RECENT REVIEW DATE: 9/22/2011
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