Coverage Policy Manual
Policy #: 2009017
Category: Surgery
Initiated: July 2009
Last Review: August 2018
  Total 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.
 
Spinal fusion is a common surgical treatment for degenerative disc disease when conservative treatment fails  However, spinal fusion alters the normal biomechanics of the back, which may potentially lead to premature disc degeneration at adjacent levels.  A variety of implants have been investigated as alternatives to rigid interbody or posterolateral intertransverse spinal fusion.  This policy addresses the implantation of prostheses intended to replace the facet joints and excised posterior elements, termed facet arthroplasty.   The objective of facet arthroplasty is to stabilize the spine while retaining normal intervertebral motion of the surgically removed segment following neural decompression.  It is proposed that facet arthroplasty should also maintain the normal biomechanics of the adjacent vertebrae.  If normal motion patterns are achieved by artificial joints in the spine, the risk of adjacent-level degeneration thought to be associated with fusion may be mitigated.
 
Regulatory Status
No facet arthroplasty devices have been approved by the U.S. Food and Drug Administration (FDA) at this time. The ACADIA™ Facet Replacement System (Facet Solutions, Hopkinton, MA) is currently being evaluated as part of an ongoing FDA-regulated investigational device exemption (IDE) Phase III trial. The Phase III trial of the Total Facet Arthroplasty System® (TFAS®, Archus Orthopedics) has been discontinued. (Facet Solutions acquired Archus Orthopedics and all of their assets in 2009. In 2011, Globus Medical acquired substantially all of the assets of Facet Solutions.) Another implant design, the Total Posterior-element System (TOPS™, Impliant Ltd., Israel), is in development and has restarted enrollment in a FDA-regulated Phase III trial in 2011 after design and manufacturing changes. Premia Spine acquired Impliant in 2011.
 

Policy/
Coverage:
Total facet arthroplasty does not meet member certificate of benefit primary coverage criteria because the procedure is being studied in clinical trials to determine safety and effectiveness. (NCT00401518 This study is ongoing, but not recruiting participants; NCT00405691 This study has been completed, results not posted)
 
For contracts without primary coverage criteria, total facet arthroplasty is considered investigational.  Investigational services are an exclusion in the member benefit certificate.
 
 

Rationale:
A search of the MEDLINE database in June 2009 identified several ex vivo biomechanical assessments in cadaver spine.  For example,  Phillips and colleagues reported a manufacturer-sponsored study that assessed the kinematics of implanted and adjacent lumbar segments in 9 human lumbar spines (L1 to sacrum) (Phillips et al, 2009).  No clinical trial results were found.
 
A clinical trial sponsored by the device developer is publicly listed (on clinicaltrials.gov) as active, but not currently recruiting.  The study is designed for patients with moderate to severe lumbar spinal stenosis requiring neural decompression with facetectomy at L3-L4 or L4-L5 at a single level to treat central or lateral stenosis, Grade I degenerative spondylolisthesis with objective evidence of neurologic impairment, and degenerative disease of the facets, with or without instability.  Specific inclusion criteria are patients between 50 and 85 years of age with degenerative spinal stenosis, central or lateral, at spinal levels L3-L4 or L4-L5, with persistent leg symptoms, including pain, numbness, burning or tingling that are refractory to at least 6 months of conservative treatment, no greater than Grade I degenerative spondylolisthesis at the index level, and no more than three levels of degenerative lumbar spinal stenosis requiring decompression.  Study participants will be randomized in a 2:1 ratio into treatment with the investigational artificial facet replacement device (TFAS™) or with standard posterior instrumented fusion.  No device has received FDA approval; therefore, there is a lack of scientific evidence that Total Facet Arthroplasty is safe or improves health outcomes.
 
2010 Update
 
A search of ClinicalTrials.gov in June 2010 showed 2 active phase III clinical trials, both sponsored by the device developers. NCT00401518 is an actively recruiting U.S. multi-center randomized trial of the ACADIA™ Facet Replacement System (Facet Solutions, Inc) compared with posterior spinal fusion. The study began in 2006, is expected to enroll around 300 subjects, and has an estimated completion of 24-month primary outcome data in 2013.
 
The posting indicates an estimated enrollment of 450 subjects beginning in 2005. The information on ClinicalTrials.gov was last updated in February 2009 (Facet Solutions acquired Archus Orthopedics and all of their assets in November 2009). A search of the FDA site shows one adverse event report in the MAUDE database for new back pain in a patient following implantation of the investigational device (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=889455).
 
2012 Update
Searches of the MEDLINE database, most recently performed through May 2012, identified a report indicating that the FDA-regulated multicenter investigational device exemption (IDE) trial (NCT00418197) of the Total Facet Arthroplasty System® (TFAS®) was discontinued due to financial reasons (Palmer, 2012). (Facet Solutions acquired Archus Orthopedics and all of their assets in November 2009). Two out of 10 TFAS procedures performed at the authors’ institution had stem fracture after total facet replacement.
 
Identified from the EMBASE database was a conference proceeding of interim results in 100 patients from the U.S. multicenter, randomized trial of the ACADIA™ Facet Replacement System (NCT00401518) (Dryer, 2010). The study began in 2006, is expected to enroll around 300 subjects with lumbar spinal stenosis, and compares facet arthroplasty with the ACADIA™ system to posterior spinal fusion. Information posted in October 2012 on the online site ClinicalTrials.gov indicates that recruitment is ongoing. Study completion is expected in 2013.
 
A search of ClinicalTrials.gov in October 2012 showed a prospective, multicenter clinical study to assess the Impliant TOPS™ system (NCT00405691), This study is listed as completed as of May 2011. The study began in 2006 with an estimated enrollment of 450 subjects with back and leg pain resulting from moderate/severe lumbar spinal stenosis at a single vertebral level between L3 to L5. The objective of the study is to compare the safety and effectiveness of the TOPS System to a control group of patients undergoing posterior spinal fusion with pedicle screws and local autograft bone.
 
At this time, no device has received FDA approval.
 
2013 Update
A search of the MEDLINE database through August 2013 did not reveal any new literature that would prompt a change in the coverage statement.
 
2014 Update
A literature search conducted through July 2014 did not reveal any new information that would prompt a change in the coverage statement.
 
2015 Update
A literature search conducted through July 2015 did not reveal any new information that would prompt a change in the coverage statement.  
   
2017 Update
A literature search conducted through July 2017 did not reveal any new information that would prompt a change in the coverage statement.
 
2018 Update
A literature search was conducted through July 2018.  There was no new information identified that would prompt a change in the coverage statement.  

CPT/HCPCS:
0202TPosterior vertebral joint(s) arthroplasty (eg, facet joint[s] replacement), including facetectomy, laminectomy, foraminotomy, and vertebral column fixation, injection of bone cement, when performed, including fluoroscopy, single level, lumbar spine

References: Myer J, Youssef JA, Rahn KA, et al.(2014) ACADIA facet replacement system IDE clinical trial: Preliminary outcomes at two-and four-years postoperative [abstract]. Spine J. 2014;11(Suppl. 1):S160-161.

NCT00401518.(2012) The Investigational Plan for the Evaluation of the ACADIA® Facet Replacement System. www.clinicaltrials.gov; last accessed 11/21/2012.

NCT00405691.(2012) A Prospective, Multi-Center Clinical Study to Assess the Saftey and Effectiveness of the Impliant TOPS System. www.clinicaltrials.gov; last accessed 11/21/2012.

Phillips FM, Tzermiadianos MN, Voronov LI, et al.(2009) Effect of the total facet arthroplasty system after complete laminectomy-facetectomy on the biomechanics of implanted and adjacent segments. Spine J 2009; 9(1):96-102.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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