Clinical UM Guideline
|Subject:||Lumbar Fusion and Lumbar Artificial Intervertebral Disc (LAID)|
|Guideline #:||CG-SURG-33||Current Effective Date:||04/07/2015|
|Status:||Revised||Last Review Date:||02/05/2015|
This document addresses two surgical procedures, lumbar fusion (also referred to as spinal fusion) and the implantation of lumbar artificial intervertebral disc (LAID) devices. Lumbar fusion refers to the surgical joining of two or more vertebrae at the lumbar levels of the spine. LAID, (which is also referred to as total disc replacement or spinal arthroplasty), refers to the surgical removal of a deteriorated lumbar disc and replacement with an artificial device, which is implanted to maintain the motion capability and structural integrity of the intervertebral space. Both lumbar fusion and LAID are proposed as treatments for chronic low back pain when conservative treatment options have been unsuccessful.
Note: For information regarding other spinal topics, see:
Note: When fusion at more than one level is planned, the criteria below apply to each level of lumbar fusion being considered. The criteria below also apply to lumbar fusion of a level adjacent to a prior lumbar fusion.
Lumbar fusion at a single level is considered medically necessary when one or more of the following indications are met (1 through 7):
*Note: Unless otherwise specified in the above criteria for lumbar fusion or below for LAID, conservative medical management, also termed conservative medical therapy, includes documentation of evaluation and management of any associated cognitive, behavioral, and addictions issues, AND two or more of the following regimens for at least 6 consecutive months with member compliance:
Not Medically Necessary:
Lumbar fusion is considered not medically necessary when the criteria listed above are not met, including but not limited to:
Lumbar Artificial Intervertebral Disc (LAID)
Lumbar artificial intervertebral disc (LAID) implantation is considered medically necessary when ALL of the following indications are met (1, 2, 3, 4, 5, AND 6):
Not Medically Necessary:
Lumbar artificial intervertebral disc (LAID) implantation is considered not medically necessary for all other indications not listed above as medically necessary.
Lumbar artificial intervertebral disc (LAID) implantation at more than one spinal level is considered not medically necessary for all indications.
Hybrid LAID/Lumbar Fusion (lumbar artificial intervertebral disc at one level at the same time as lumbar fusion at a different level) is considered not medically necessary.
The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
|22533||Arthrodesis, lateral extracavitary technique, including minimal discectomy to prepare interspace (other than for decompression); lumbar|
|22534||Arthrodesis, lateral extracavitary technique, including minimal discectomy to prepare interspace (other than for decompression); thoracic or lumbar, each additional vertebral segment|
|22558||Arthrodesis, anterior interbody technique, including minimal discectomy to prepare interspace (other than for decompression); lumbar|
|22585||Arthrodesis, anterior interbody technique, including minimal discectomy to prepare interspace (other than for decompression); each additional interspace|
|22612||Arthrodesis, posterior or posterolateral technique, single level; lumbar (with lateral transverse technique, when performed)|
|22614||Arthrodesis, posterior or posterolateral technique, single level; each additional vertebral segment|
|22630||Arthrodesis, posterior interbody technique, including laminectomy and/or discectomy to prepare interspace (other than for decompression), single interspace; lumbar|
|22632||Arthrodesis, posterior interbody technique, including laminectomy and/or discectomy to prepare interspace (other than for decompression); each additional interspace|
|22633||Arthrodesis, combined posterior or posterolateral technique with posterior interbody technique including laminectomy and/or discectomy sufficient to prepare interspace (other than for decompression), single interspace and segment; lumbar|
|22634||Arthrodesis, combined posterior or posterolateral technique with posterior interbody technique including laminectomy and/or discectomy sufficient to prepare interspace (other than for decompression), single interspace and segment; each additional interspace and segment|
|22857||Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression), single interspace, lumbar|
|22862||Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, single interspace; lumbar|
|0163T||Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression), each additional interspace, lumbar|
|0165T||Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, each additional interspace, lumbar|
|ICD-9 Procedure||[For dates of service prior to 10/01/2015]|
|81.05||Dorsal and dorsolumbar fusion of the posterior column, posterior technique|
|81.06||Lumbar and lumbosacral fusion of the anterior column, anterior technique|
|81.07||Lumbar and lumbosacral fusion of the posterior column, posterior technique|
|81.08||Lumbar and lumbosacral fusion of the anterior column, posterior technique|
|81.36||Refusion of lumbar and lumbosacral spine, anterior column, anterior technique|
|81.37||Refusion of lumbar and lumbosacral spine, posterior column, posterior technique|
|81.38||Refusion of lumbar and lumbosacral spine, anterior column, posterior technique|
|84.65||Insertion of total spine disc prosthesis, lumbosacral|
|84.68||Revision or replacement of artificial spinal disc prosthesis, lumbosacral|
|ICD-9 Diagnosis||[For dates of service prior to 10/01/2015]|
|All diagnoses, including, but not limited to:|
|170.2||Malignant neoplasm bone and articular cartilage, vertebral column, excluding sacrum and coccyx|
|213.2||Benign neoplasm of bone and articular cartilage, vertebral column, excluding sacrum and coccyx|
|721.3||Lumbosacral spondylosis without myelopathy|
|721.42||Lumbar spondylosis with myelopathy, lumbar region|
|721.5-721.91||Other spondylosis and allied disorders|
|722.10||Displacement of lumbar intervertebral disc without myelopathy|
|722.2||Displacement of intervertebral disc, site unspecified without myelopathy|
|722.52||Degeneration of lumbar or lumbosacral intervertebral disc|
|722.73||Intervertebral disc disorder with myelopathy, lumbar region|
|722.83||Postlaminectomy syndrome, lumbar region|
|722.93||Other and unspecified disc disorder, lumbar region|
|724.02-724.03||Spinal stenosis, lumbar region, without/with neurogenic claudication|
|724.2-724.6||Lumbago, sciatica, neuritis or radiculitis, backache, instability|
|730.08||Acute osteomyelitis, other specified sites (abscess, spine)|
|733.82||Nonunion of fracture (pseudarthrosis)|
|805.4-805.5||Fracture of vertebral column without mention of spinal cord injury, lumbar|
|806.4-806.5||Fracture of vertebral column with spinal cord injury, lumbar|
|839.20||Dislocation lumbar vertebra, closed|
|839.30||Dislocation lumbar vertebra, open|
|ICD-10 Procedure||[For dates of service on or after 10/01/2015]|
|0SG0070-0SG04ZJ||Lumbar vertebral joint fusion [by approach; includes codes 0SG0070, 0SG0071, 0SG007J, 0SG00A0, 0SG00A1, 0SG00AJ, 0SG00J0, 0SG00J1, 0SG00JJ, 0SG00K0, 0SG00K1, 0SG00KJ, 0SG00Z0, 0SG00Z1, 0SG00ZJ, 0SG0470, 0SG0471, 0SG047J, 0SG04A0, 0SG04A1, 0SG04AJ, 0SG04J0, 0SG04J1, 0SG04JJ, 0SG04K0, 0SG04K1, 0SG04KJ, 0SG04Z0, 0SG04Z1, 0SG04ZJ]|
|0SG1070-0SG14ZJ||Lumbar vertebral joint fusion, 2 or more [by approach, includes codes 0SG1070, 0SG1071, 0SG107J, 0SG10A0, 0SG10A1, 0SG10AJ, 0SG10J0, 0SG10J1, 0SG10JJ, 0SG10K0, 0SG10K1, 0SG10KJ, 0SG10Z0, 0SG10Z1, 0SG10ZJ, 0SG1470, 0SG1471, 0SG147J, 0SG14A0, 0SG14A1, 0SG14AJ, 0SG14J0, 0SG14J1, 0SG14JJ, 0SG14K0, 0SG14K1, 0SG14KJ, 0SG14Z0, 0SG14Z1, 0SG14ZJ]|
|0SG3070-0SG34ZJ||Lumbosacral joint fusion [by approach, includes codes 0SG3070, 0SG3071, 0SG307J, 0SG30A0, 0SG30A1, 0SG30AJ, 0SG30J0, 0SG30J1, 0SG30JJ, 0SG30K0, 0SG30K1, 0SG30KJ, 0SG30Z0, 0SG30Z1, 0SG30ZJ, 0SG3470, 0SG3471, 0SG347J, 0SG34A0, 0SG34A1, 0SG34AJ, 0SG34J0, 0SG34J1, 0SG34JJ, 0SG34K0, 0SG34K1, 0SG34KJ, 0SG34Z0, 0SG34Z1, 0SG34ZJ]|
|0SR20JZ||Replacement of lumbar vertebral disc with synthetic substitute, open approach|
|0SR40JZ||Replacement of lumbosacral disc with synthetic substitute, open approach|
|0SW20JZ-0SW24JZ||Revision of synthetic substitute in lumbar vertebral disc [by approach; includes codes 0SW20JZ, 0SW23JZ, 0SW24JZ]|
|0SW40JZ-0SW44JZ||Revision of synthetic substitute in lumbosacral disc [by approach; includes codes 0SW40JZ, 0SW43JZ, 0SW44JZ]|
|ICD-10 Diagnosis||[For dates of service on or after 10/01/2015]|
|All diagnoses, including, but not limited to:|
|C41.2||Malignant neoplasm of vertebral column|
|D16.6||Benign neoplasm of vertebral column|
|M43.06-M43.07||Spondylolysis, lumbar/lumbosacral region|
|M43.16-M43.17||Spondylolisthesis, lumbar/lumbosacral region|
|M43.5X6-M43.5X7||Other recurrent vertebral dislocation, lumbar/lumbosacral region|
|M46.26-M46.27||Osteomyelitis of vertebra, lumbar/lumbosacral region|
|M47.16||Other spondylosis with myelopathy, lumbar region|
|M47.26-M47.27||Other spondylosis with radiculopathy, lumbar/lumbosacral region|
|M47.816-M47.817||Spondylosis without myelopathy or radiculopathy, lumbar/lumbosacral region|
|M48.06-M48.07||Spinal stenosis, lumbar/lumbosacral region|
|M48.16-M48.17||Ankylosing hyperostosis (Forestier), lumbar/lumbosacral region|
|M48.26-M48.27||Kissing spine, lumbar/lumbosacral region|
|M48.36-M48.37||Traumatic spondylopathy, lumbar/lumbosacral region|
|M48.46XS-M48.47XS||Fatigue fracture of vertebra, lumbar/lumbosacral region, sequela|
|M48.56XS-M48.57XS||Collapsed vertebra, not elsewhere classified, lumbar/lumbosacral region, sequela|
|M51.06||Intervertebral disc disorders with myelopathy, lumbar region|
|M51.16-M51.17||Intervertebral disc disorders with radiculopathy, lumbar/lumbosacral regions|
|M51.26-M51.27||Other intervertebral disc displacement, lumbar/lumbosacral region|
|M51.36-M51.37||Other intervertebral disc degeneration, lumbar/lumbosacral region|
|M51.86-M51.87||Other intervertebral disc disorders, lumbar/lumbosacral region|
|M53.2X6-M53.2X7||Spinal instabilities, lumbar/lumbosacral region|
|M53.86-M53.87||Other specified dorsopathies, lumbar/lumbosacral region|
|M54.16-M54.17||Radiculopathy, lumbar/lumbosacral region|
|M96.0-M96.1||Pseudarthrosis after fusion or arthrodesis, postlaminectomy syndrome, not elsewhere classified|
|S32.000A-S32.059S||Fracture of lumbar vertebra|
|S33.0XXA-S33.0XXS||Traumatic rupture of lumbar intervertebral disc|
|S33.100A-S33.141S||Subluxation and dislocation of lumbar vertebra|
Although chronic low back pain (CLBP) does not always have a precisely identifiable cause, the following conditions can contribute to persistent low back pain: degenerative disc disease (DDD), muscle strain, skeletal trauma, infection and tumor. Chronic low back pain without an identifiable and verifiable source of pain (usually confirmed by magnetic resonance imaging [MRI] or computed tomography [CT] imaging) is termed chronic nonspecific low back pain (CNLBP) and is often attributed to DDD. In the U.S., DDD affects 40-50% of people over the age of 40 and becomes increasingly common with advancing age. Although it can occur at any spinal level, it is most common in the lumbar spine (low back). Disc degeneration is a complex biochemical process that occurs with the loss of normal water content within the disc resulting in the deterioration of the mechanical shock absorbing properties of the disc over time. This will lead to bulging and decreased disc height. The cause most often attributed to DDD is the natural aging process, although various associated factors, (such as presence of osteoarthritis), may accelerate the process. Although not all individuals with DDD complain of symptomatic pain, the majority of afflicted persons will eventually develop painful symptoms associated with the motion of normal daily activities, (for example, walking short distances or standing for any extended period of time).
Lumbar fusion (LF) has been a surgical treatment option for the symptoms of DDD when noninvasive medical treatment options have failed. The procedure removes the damaged areas of the vertebral disc and fuses the remaining vertebral segments, which eliminates motion between adjacent vertebral segments, with resultant reduction in associated back pain. However, LF alters the biomechanics of the back, potentially leading to premature disc degeneration at adjacent levels of the spine. Complications following LF are reported in approximately 10% of all cases, including nonunion and loss of spinal curvature and flexibility. The existing literature has demonstrated that both nonsurgical treatment and LF surgery may improve function and pain for individuals with CLBP attributed to DDD. However, the published evidence and systematic reviews, in favor of LF as the more beneficial treatment for the symptomatic relief of DDD, have been limited by methodological flaws and inconsistencies which have prevented the formulation of specific recommendations for fusion surgery in this population (Brox, 2003; Brox, 2006; Brox, 2010; Carreon, 2008; Chou, 2009; Fritzell, 2001; Mirza, 2007). More recent systematic literature reviews, comparative trials and meta-analyses with extended follow-up data (2–11 years) have demonstrated similar results that do not show superior clinical outcomes for surgical versus nonsurgical medical management of DDD (Andrade, 2013; Fairbank, 2005; Mannion, 2013; Ohtori, 2011; Saltychev, 2014).
The Spine Patient Outcomes Research Trial (SPORT) was funded by the National Institutes of Health (NIH) to study the outcomes from surgical and nonsurgical management of three conditions: intervertebral disk herniation, degenerative spondylolisthesis, and lumbar spinal stenosis. Both surgical and nonsurgical care of intervertebral disk herniation resulted in significant improvement in symptoms of low back and leg pain. However, the treatment effect of surgery for intervertebral disk herniation was less than that seen in individuals with degenerative spondylolisthesis and lumbar spinal stenosis. The preliminary 4 year outcomes data demonstrated more significant degrees of improvement in pain levels and function with surgical versus nonsurgical treatment in the chronic conditions of lumbar spinal stenosis and lumbar spinal stenosis with spondylolisthesis (Asghar, 2012; Weinstein, 2006a; Weinstein, 2006b; Weinstein, 2007; Weinstein, 2009).
According to the American Association of Neurological Surgeons/Congress of Neurological Surgeons (AANS/CNS) Guidelines for the Performance of Fusion Procedures for Degenerative Disease of the Lumbar Spine (Resnick, 2005a, 2005b), LF is not recommended for spinal stenosis in the absence of deformity, (such as spondylolisthesis, scoliosis, or regional kyphosis) or instability (pre-existing or iatrogenic). However, there is evidence of durable clinical improvement in carefully selected subjects with risk factors for progressive instability or deformity when the CLBP has been intractable to best medical management (Weinstein, 2009).
Treatment of spondylolisthesis with LF is the most common surgical approach with documented results in the published literature. The largest reported series is from the Scoliosis Research Society, where they describe results of 10,242 surgically treated cases of adult spondylolisthesis. Out of 10,242 trial participants, only 532 were treated without LF. Complication rates in subjects undergoing LF, versus those undergoing decompression alone, were not significantly different. It is generally understood in the practice community that degenerative symptomatic spondylolisthesis is treated with LF due to the reported risks of deformity progression and chronic pain in the majority of those treated without LF (Sansur, 2010; Weinstein, 2009).
For individuals with persistent and disabling radiculopathy due to herniated lumbar disc or persistent and disabling leg pain due to spinal stenosis, the American Pain Society (APS) Low Back Pain Guideline Panel developed guidelines for interventional therapies, surgery, and interdisciplinary rehabilitation for CLBP. This APS guideline recommended that clinicians discuss risks and benefits of surgery as an "Option" (that is, strong recommendation, high-quality evidence). It is further recommended that shared decision-making regarding surgery include a specific discussion about moderate/average benefits, which appear to decrease over time in affected individuals who undergo surgery (Chou, 2009).
Lumbar Artificial Intervertebral Disc (LAID):
Lumbar artificial intervertebral discs (LAID) have been developed as an alternative to spinal fusion. This approach is intended to maintain the disc height and physiologic motion capability of the artificial disc device, as well as the adjacent vertebrae and, as such, is purported to be a beneficial alternative to spinal fusion. Proposed candidates for LAID have chronic low back pain attributed to DDD, which has been refractory to conservative noninvasive treatments, such as physical therapy and non-steroidal anti-inflammatory drugs (NSAIDs). Contraindications to LAID include: multilevel disc disease, spinal stenosis or spondylolisthesis, scoliosis, previous major spine surgery, and neurologic symptoms.
In 2012, an updated technology assessment report on Total Disc Replacement for Chronic Low-back Pain from the Cochrane Database concluded that:
The spine surgery community should be prudent about adopting this technology on a large scale, despite the fact that total disc replacement seems to be effective in treating low-back pain in selected patients, and in the short term is at least equivalent to fusion surgery (Jacobs, 2012).
In 2007, the California Technology Assessment Forum (CTAF) updated its review of the scientific literature on the Safety and Efficacy of Artificial Spinal Disc Replacement for the Treatment of Low Back Pain caused by Lumbar Degenerative Disc Disease, in which neither the Charité nor the ProDisc device met criteria for safety, effectiveness and improvement in health outcomes when used to treat pain and disability from DDD of the lumbar spine. The following is excerpted: "Despite the promising results of the two randomized trials, it is not clear that possible benefits of the artificial discs outweigh the attendant surgical risks and the possibility of long-term device failure" (CTAF, 2007).
In 2009, the National Institute for Health and Clinical Excellence (NICE) published an update to their 2005 guidance on Intervertebral Lumbar Disc Prosthesis which considered the evidence on safety and efficacy adequate to support use of the procedure under normal arrangements. The report stated:
A multi-disciplinary team with specialist expertise in the treatment of degenerative spine disease should be involved in patient selection for prosthetic intervertebral disc replacement in the lumbar spine. The procedure should only be carried out in patients for whom conservative treatment options have failed or are contraindicated (NICE, 2009).
In 2007, the Blue Cross Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) published an evaluation of AID of the lumbar spine which was based on the available evidence (case series and randomized controlled trials for the Charité and ProDisc). This TEC Report concluded that the evidence was insufficient to determine if use of artificial lumbar discs improved net health outcomes or were as beneficial as established alternatives (that is, LAID did not meet the TEC Criteria). The TEC also concluded that the effectiveness of spinal fusion for chronic DDD is not well established (TEC, 2007).
Currently, only two LAID devices (Charité® [replaced by the INMOTION®] and ProDisc®-L) have been cleared by the U.S. Food and Drug Administration (FDA), contingent on completion of post-marketing studies regarding device safety and efficacy. The Charité Artificial Disc ((DePuy Spine Inc., Raynham, MA) and ProDisc-L Total Disc Replacement (Synthes Spine Inc., West Chester, PA) are indicated for spinal arthroplasty in skeletally mature individuals with DDD at 1 level with FDA-specified grades of spondylolisthesis present at the involved spinal level and evidence of at least 6 months of prior failed conservative treatment without relief of associated back pain. The Charité device was cleared for use in levels L4–S1, and the ProDisc-L device was cleared for use in levels L3–S1. Notably, production of the Charité disc was stopped in 2010, and it was withdrawn from the U.S. market. The INMOTION Lumbar Artificial Disc System (DePuy Spine, Inc., Raynham, MA) is a modification of the Charité design which has also been cleared by the FDA. Other devices are currently under investigation, including the FlexiCore™ Intervertebral Disc (Stryker Spine, Allendale, NJ), Maverick (Medtronic Sofamor Danel, Memphis, TN), and Activ-L™ (Aesculap, Center Valley, PA).
Initial FDA clearance of the Charité device was based on 2 year safety and effectiveness data from a multicenter, prospective, randomized investigational device exemption (IDE) study, the CHARITE IDE trial, which was conducted by the manufacturer at 6 medical centers. A total of 304 individuals enrolled in the study; 205 were randomized to the Charité disc-treated group and 99 to anterior lumbar interbody fusion involving BAK cages and iliac crest bone grafting (fusion-treated control group). Neurological status was equivalent between the 2 groups at 6, 12, and 24 months postoperatively. The number of trial participants with major, minor, or other neurological complications was equivalent. There was a greater incidence of both major and minor complications in the BAK fusion group at 0 to 42 days postoperatively. It was noted that, compared with data reported in the lumbar fusion literature, the Charité disc-treated subjects had equivalent or better mean changes in visual analog scale (VAS) and Oswestry Disability Index (ODI) scores. The authors concluded that use of the Charité artificial disc is safe and effective for the treatment of single-level lumbar DDD, resulting in no higher incidence of neurological complications compared with BAK-assisted fusion and leading to equivalent or better outcomes compared with those obtained in the control group and those reported in the lumbar fusion literature. An additional randomized controlled trial, performed as part of the FDA-mandated IDE studies, had similar favorable results at 24 months follow-up for use of the Charité device, in comparison to anterior lumbar interbody fusion for the treatment of single-level DDD from L4-S1 that had been unresponsive to nonoperative treatment (Geisler, 2004; McAfee, 2005).
Subsequent 5-year data was reported by Guyer for the treatment of single-level DDD from L4 to S1, that had been unresponsive to nonoperative treatment. Of the 375 subjects enrolled in the CHARITE IDE trial, 277 were eligible for the 5 year study, of which 160 subjects completed the 5 year follow-up. Overall success was defined as improvement (> 15 points in validated ODI vs. baseline, no device failure, absence of major complications, and maintenance or improvement of neurological status). Additional clinical outcomes included an ODI questionnaire, as well as a VAS, short form (SF-36), and individual satisfaction surveys. Work status was tracked for all participants. Safety assessments included occurrence and severity of adverse events and device failures. Radiographic analyses, such as index- and adjacent-level range of motion (ROM), segmental translation, disc height, and longitudinal ossification, were also carried out. Overall success was 57.8% in the CHARITE group vs. 51.2% in the BAK group (Blackwelder's test: p=0.0359; Delta=0.10). In addition, mean changes from baseline for ODI (CHARITE: -24.0 vs. BAK: -27.5), VAS pain scores (CHARITE: -38.7 vs. BAK: -40.0), and SF-36 questionnaires (SF-36 Physical Component Scores [PCS]: CHARITE: 12.6 vs. BAK: 12.3) were similar across groups. Regarding the satisfaction surveys, 78% of CHARITE subjects were satisfied vs. 72% of BAK recipients. A total of 65.6% in the CHARITE group vs. 46.5% in the BAK group were employed full-time. This difference was statistically significant (p=0.0403). Long-term disability was recorded for 8.0% of CHARITE subjects and 20.9% of BAK recipients, a difference that was also statistically significant (p=0.0441). Additional index-level surgery was performed in 7.7% of CHARITE subjects and 16.3% of BAK subjects. At the 5 year follow-up, the mean ROM at the index level was 6.0 degrees for CHARITE subjects and 1.0 degrees for BAK recipients. Changes in disc height were also similar for both CHARITE and BAK groups (0.7 mm for both groups, p=0.9827). Segmental translation was 0.4 and 0.8 mm in those implanted with CHARITE at L4-L5 vs. L5-S1, respectively, and 0.1 mm in BAK recipients. The investigators concluded that the 5 year results were consistent with the 2 year reports of noninferiority of the CHARITE artificial disc vs. anterior lumbar interbody fusion with BAK and iliac crest autograft. No statistical differences were found in clinical outcomes between groups. In addition, the CHARITE subjects reached a statistically greater rate of part- and full-time employment and a statistically lower rate of long-term disability, compared with BAK subjects. Radiographically, the ROMs at index and adjacent levels were not statistically different from those observed at 2 years postsurgery (Blumenthal, 2005; Guyer, 2009).
Initial FDA clearance of the ProDisc-L device was based on early results of a multicenter, prospective, randomized controlled clinical trial of 292 subjects (162 randomized, 50 nonrandomized, and 80 control subjects). The control group was treated for DDD at a single level between L3 to S1 using a circumferential fusion technique (that is, interbody fusion with femoral ring allograft, posterolateral fusion with autogenous iliac crest bone graft, combined with pedicle screw instrumentation). The randomized subjects received implantations of the ProDisc-L via an anterior surgical approach, with no additional instrumentation used to secure the device placement. Early results showed a non-inferiority margin of 10% with an overall success rate for the ProDisc group that was no worse than the overall success rate of the control group (Zigler, 2007). Five year outcomes data were published in 2012, as part of the FDA-required post-market approval study. A total of 236 subjects were treated and followed for 5 years; 161 total disc replacements (TDR) and 75 fusions had been performed. The primary outcome was a 10-component success endpoint. Secondary outcome measures included neurological status, secondary surgery, ODI, 36-Item SF, VAS assessing pain and satisfaction, radiographic data, narcotic use, activity, and recreation status. The trial participants were monitored through their 5 year postoperative visits under the FDA postmarket surveillance provisions in the original IDE approval. The overall follow-up rate at 5 years was 81.8%. Study success demonstrated that TDR was noninferior to fusion with a 12.5% margin (p=0.0099). Both TDR and fusion treatment groups maintained significant improvements on the ODI at 5 years compared with baseline (p<0.0001). Secondary surgeries at the index level were performed in 12% of fusion subjects and 8% of TDR subjects. Radiographically, none of the TDRs developed spontaneous fusion. The segmental ROM following TDR remained within normal range, although it decreased by approximately 0.5° in years 3 to 5. The VAS pain scores decreased from preoperative values by 48% in both treatment groups at 5 years. Individual satisfaction remained high in both groups (77%), while the percentage of subjects indicating that they would have the surgery again was higher in the TDR group (82.5%) than in the fusion group (68.0%). The investigators concluded that both groups maintained significant improvements during the 5 year follow-up. The TDR group had significantly better improvements on some scales. Although the TDR subjects avoided the stiffness of fusion and were more satisfied than the subjects in the fusion group, both fusion and TDR procedures were demonstrated to be reasonable surgical options in this specific population (Zigler, 2012).
Additional published evidence, primarily composed of case series, retrospective case reviews and observational studies, continues to be studied in ongoing efforts to isolate the subsets of individuals with lower back pain who will benefit the most from use of LAID device implantation (Bertagnoli, 2005, 2006; Delamarter, 2011; Siepe, 2006, 2012).
Arthrodesis (also known as spinal fusion): This surgical procedure involves the joining of two or more lumbar vertebrae together into one solid bony structure.
Arthroplasty (which is also referred to as lumbar artificial intervertebral disc [LAID] or total disc replacement): A surgical procedure in which an artificial joint replaces a damaged joint.
Burst fracture: Injury to the spine in which the vertebral body is severely compressed. These fractures typically occur from severe trauma, such as a motor vehicle accident or a fall from a height. The degree of neurologic injury is usually due to the amount of force that is present at the time of the injury and the amount of compromise of the spinal canal.
Chronic nonspecific low back pain (CNLBP): This term refers to persistent low back pain that is not attributable to an identifiable or known specific pathology, such as infection, tumor, osteoporosis, fracture, structural deformity (for example, spondylolisthesis or scoliosis), inflammatory disorder, radiculitis, or cauda equine syndrome.
Degenerative disc disease (DDD): Discogenic back pain (that is, emanating from the vertebral disc) associated with degenerative arthritic changes in the disc, which can be visualized by imaging technology (x-ray, MRI).
Degenerative lumbar scoliosis: This is also known as adult scoliosis or adult onset scoliosis, describes a side-to-side curvature of the spine caused by degeneration of the facet joints. The condition occurs most frequently in people over 65 years of age. The scoliosis curve, which typically forms a "C" shape, is located in the lumbar spine.
Intervertebral disc: The soft tissues located between each vertebra; these discs act as cushions between the vertebrae during normal motion.
Modic changes: This term refers to pathological changes visualized by MRI in the bones of the spine (the vertebrae); which are present in both the body of the vertebrae and the endplate of the neighboring disc. There are 3 types of Modic changes described as follows:
Oswestry Disability Index (ODI): A recognized method of scoring which reflects the impact of back pain on daily function; it is considered a reliable and valid measure of functional disability related to back pain and is widely used in the practice community.
Pars defect: Injury to the spine in which the articulating surface of the vertebrae slips forward (spondylolisthesis) due to a fracture.
Pseudoarthrosis: This term refers to the bony nonunion of a prior spinal fusion surgery.
Radiculopathy: The irritation of a nerve root at any level of the spine which can be caused by protrusion of a disc.
Scoliosis: Refers to curvature of the spine which may be congenital or idiopathic; this condition may become symptomatic in childhood or later in life.
Spinal stenosis: Refers to narrowing and compression within the anatomical regions of the vertebrae; depending on location, stenosis may result in nerve root compression.
Spondylolisthesis: Forward slippage of one vertebral body with impingement upon the adjacent inferior disc.
The Myerding Grading System measures the percentage of vertebral slip forward over the body beneath:
Grade 1 -- 25 % of vertebral body has slipped forward;
Grade 2 -- 25 % to 49 % of vertebral body has slipped forward;
Grade 3 -- 50 % to 74 % of vertebral body has slipped forward;
Grade 4 -- 75 % to 99 % of vertebral body has slipped forward;
Grade 5 -- Vertebral body has completely fallen off (that is, spondylolysis)
(Adapted from: Vokshoor A. Spondylolisthesis, spondylolysis, and spondylosis. eMedicine. Orthopedic Topic 560. Omaha, NE: eMedicine.com: Updated June 30, 2004.)
Spondylolysis: A defect in a specific region (the pars interarticularis) of a vertebral body with detachment and separation of the vertebral joints. This condition can result in slippage of the involved vertebral disc (spondylolisthesis).
Vertebrae: Bones that make up the spinal column which surround and protect the spinal cord.
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|Websites for Additional Information|
Artificial Intervertebral Disc Replacement (AID)
Charité Artificial Disc
InMotion Lumbar Artificial Disc System
Lumbar Artificial Intervertebral Disc (LAID)
ProDisc-L Total Disc Replacement
Total Disc Replacement (TDR)
The use of specific product names is illustrative 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.
|Revised||02/05/2015||Medical Policy & Technology Assessment Committee (MPTAC) review. Minor editorial edits were made to the Clinical Indications section for lumbar fusion and LAID and to the Note regarding what is meant by conservative medical management/therapy for clarification. The Coding, Definitions and References sections were updated.|
|Revised||11/13/2014||MPTAC review. A note has been added to the position statement section for lumbar fusion to clarify and define conservative medical management with a timeframe for preoperative medical therapy. The Discussion, Definitions and References sections were updated.|
|Revised||02/13/2014||MPTAC review. No change to current criteria except for a Note clarification to indicate that lumbar fusion at more than one level or lumbar fusion of a level adjacent to a prior lumbar fusion must also meet the current medically necessary criteria. References were updated.|
|New||05/09/2013||MPTAC review. Initial document development.|