Clinical UM Guideline

 

Subject: Lumbar Fusion and Lumbar Total Disc Arthroplasty
Guideline #:  CG-SURG-33 Publish Date:    02/28/2018
Status: Revised Last Review Date:    01/25/2018

Description

This document addresses two surgical procedures, lumbar fusion (also referred to as spinal fusion) and the implantation of lumbar total disc arthroplasty (TDA) devices. Lumbar fusion refers to the surgical joining of two or more vertebrae at the lumbar levels of the spine. TDA, (which is also referred to as total disc replacement [TDR] or lumbar artificial intervertebral disc [LAID], 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 TDA are proposed as treatments for chronic low back pain when conservative treatment options have been unsuccessful.

Note: For information regarding other spinal topics, see:

Clinical Indications

Lumbar Fusion 

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.

Medically Necessary:

Lumbar fusion at a single level is considered medically necessary when one or more of the following indications are met (A through F):

  1. The individual has symptomatic spondylolisthesis confirmed on x-ray and 1, 2, or 3 are met:
    1. Age greater than 18 years with low or high grade spondylolisthesis and persistent symptomatic pain or functional impairment, despite at least 6 months of appropriate conservative treatment*; or
    2. Age 18 years or less with high-grade (50% or more anterior slippage) spondylolisthesis; or
    3. The individual has progressive or severe neurologic deficits (for example, bowel or bladder dysfunction, limb weakness);
      or
  2. The individual has symptomatic lumbar spinal stenosis and meets all of the following:
    1. The stenosis is moderate to severe; and
    2. There is clinically significant functional impairment, despite at least 3 months of conservative medical therapy*; and
    3. The individual meets one or more of the following:
      1.  Lumbar spondylolisthesis demonstrated on x-ray; or
      2.  Spinal instability demonstrated on imaging studies; or
      3. Spinal instability is anticipated due to need for bilateral or wide decompression with facetectomy or resection of pars interarticularis;
        or
  3. The individual has a spinal fracture and evidence of spinal instability (for example, burst fracture) or neural compression
    or
  4. The individual is undergoing a spinal repair with fusion for instability due to extensive surgery when performed with other procedures (for example, laminectomy) for neural decompression, fracture, dislocation, infection, abscess, or tumor;
    or
  5. The individual has symptomatic lumbar pseudarthrosis and it has been at least 6 months since the initial fusion and all of the following are met:
    1. The pseudarthrosis is documented radiographically; and
    2. There is persistent axial pain with clinically significant functional impairment, despite at least 3 months of conservative medical management*; and
    3. Symptomatic relief had been demonstrated after the initial fusion;
      or
  6. The individual requires disc excision or re-operative discectomy and has radiculopathy secondary to a herniated disc and radiographic evidence of lumbar spinal instability (for example, spondylolisthesis).

*Note: Unless otherwise specified in the above criteria for lumbar fusion or below for lumbar total disc arthroplasty (TDA), 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 Total Disc Arthroplasty

Medically Necessary:

Lumbar total disc arthroplasty is considered medically necessary when all of the following indications are met (A through F):

  1. Spondylolisthesis for:
    Adults (age greater than 18) with persistent and significant symptoms, despite an adequate trial of at least 6 months of conservative medical therapy* with low-grade spondylolisthesis demonstrated on x-ray; and
  2. Degenerative disc disease is limited to the single spinal level at which the lumbar TDA is planned; and
  3. An FDA approved lumbar total disc arthroplasty device is used in accordance with FDA labeling (including any label requirements regarding the degree of spondylolisthesis); and
  4. A single level in the lumbar spine will be treated with a lumbar total disc arthroplasty device; and  
  5. The individual is skeletally mature; and  
  6. There are no contraindications to lumbar total disc arthroplasty device implantation, (including those listed in the FDA labeling), including, but not limited to the following:
    1. Active systemic infection or infection localized to the site of implantation; or
    2. Bone density which does not meet the minimum level specified for the implanted device*;  or
    3. Bony lumbar spinal stenosis; or
    4. Isolated radicular compression syndromes, especially due to disc herniation; or
    5. Pars defect; or
    6. Clinically compromised vertebral bodies at affected level due to current or past trauma; or
    7. Lytic spondylolisthesis or degenerative spondylolisthesis of grade greater than 1; or
    8. Significant facet joint or zygohypophaseal joint changes.

*A dual energy X-Ray absorptiometry (DEXA) scan is not required for all individuals, but is indicated for individuals with an increased risk of osteoporosis; see CG-MED-39 Central (Hip or Spine) Bone Density Measurement and Screening for Vertebral Fractures Using Dual Energy X-Ray Absorptiometry. See Appendix A FDA device specific definitions of inadequate bone density, as defined by DEXA T-score for minimum bone density specifications (T-score) for each lumbar artificial intervertebral disc device.

Not Medically Necessary:

Lumbar total disc arthroplasty is considered not medically necessary for all other indications not listed above as medically necessary.

Lumbar total disc arthroplasty at more than one spinal level is considered not medically necessary for all indications.

Hybrid lumbar total disc arthroplasty/lumbar fusion (lumbar total disc arthroplasty at one level at the same time as lumbar fusion at a different level) is considered not medically necessary.

Coding

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.

CPT

 

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-10 Procedure

 

0SG0070-0SG04ZJ

Lumbar vertebral joint fusion [by approach; includes codes 0SG0070, 0SG0071, 0SG007J, 0SG00A0, 0SG00AJ, 0SG00J0, 0SG00J1, 0SG00JJ, 0SG00K0, 0SG00K1, 0SG00KJ, 0SG00Z0, 0SG00Z1, 0SG00ZJ, 0SG0470, 0SG0471, 0SG047J, 0SG04A0, 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, 0SG10AJ, 0SG10J0, 0SG10J1, 0SG10JJ, 0SG10K0, 0SG10K1, 0SG10KJ, 0SG10Z0, 0SG10Z1, 0SG10ZJ, 0SG1470, 0SG1471, 0SG147J, 0SG14A0, 0SG14AJ, 0SG14J0, 0SG14J1, 0SG14JJ, 0SG14K0, 0SG14K1, 0SG14KJ, 0SG14Z0, 0SG14Z1, 0SG14ZJ]

0SG3070-0SG34ZJ

Lumbosacral joint fusion [by approach, includes codes 0SG3070, 0SG3071, 0SG307J, 0SG30A0, 0SG30AJ, 0SG30J0, 0SG30J1, 0SG30JJ, 0SG30K0, 0SG30K1, 0SG30KJ, 0SG30Z0, 0SG30Z1, 0SG30ZJ, 0SG3470, 0SG3471, 0SG347J, 0SG34A0, 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

 

 

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

 

M48.061-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

 

Discussion/General Information

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

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).

In 2015, a new implant device was cleared by the FDA, the Aesculap T-Space PEEK and XP Spinal System (Aesculap Implant Systems, LLC, Center Valley, PA), as an intervertebral body fusion system.  This device uses cobalt chromium endplates to affix to the vertebrae with bone-sparing spikes providing initial stabilization.  The FDA clearance is for the following indication, subject to at least 6 months of prior non-operative treatment failure before this device can be implanted:

The Aesculap T-Space (AIS T) Spinal Implant System is indicated for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at involved levels. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). The AIS T-Space Spinal Implant System is intended for use with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The AIS T-Space Spinal Implant System implants can be used individually or in pairs. The AIS T-Space Spinal Implant System is also intended for use with autogenous bone graft (FDA, 2015).

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 Total Disc Arthroplasty (TDA)

Lumbar total disc arthroplasty (TDA) has 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 lumbar TDA have CLBP attributed to DDD, which has been refractory to conservative noninvasive treatments, such as physical therapy and NSAIDs. Contraindications to lumbar TDA include: multilevel disc disease, spinal stenosis or advanced (that is, beyond Grade I) or lytic spondylolisthesis, scoliosis, previous major spine surgery, and neurologic symptoms.

In 2012, an updated technology assessment report on Total Disc Replacement for CLBP 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 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, lumbar TDA 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).

Two lumbar TDA devices (Charité® [replaced by the INMOTION®] and ProDisc®-L) were originally 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 one 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) and the Maverick (Medtronic Sofamor Danek, Memphis, TN).

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 six 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 noninferiority 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). Outcomes data at 5 years 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 TDA 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 TDA was noninferior to fusion with a 12.5% margin (p=0.0099). Both TDA 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 TDA subjects. Radiographically, none of the TDAs developed spontaneous fusion. The segmental ROM following TDA 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 TDA 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 TDA group had significantly better improvements on some scales. Although the TDA subjects avoided the stiffness of fusion and were more satisfied than the subjects in the fusion group, both fusion and TDA procedures were demonstrated to be reasonable surgical options in this specific population (Zigler, 2012).

In 2015, the activL® artificial disc (Aesculap Implant Systems, LLC, Center Valley, PA), obtained FDA clearance for lumbar TDA at a single level. According to the manufacturer, “It is the first mobile ultra-high molecular weight polyethylene core that supports both controlled translational and rotational movement similar to the movement of the healthy lumbar spine.” The FDA clearance was based on an Investigational Device Exemption (IDE) trial which demonstrated noninferiority in overall trial success (p < 0.0001), compared to conventional TDA designs and fusion surgery outcomes. The FDA clearance is for the following indication, subject to at least 6 months of prior non-operative treatment failure before this device is implanted:

The activL artificial disc (activL) is indicated for reconstruction of the disc at one level (L4-L5 or L5-S1) following single-level discectomy in skeletally mature patients with symptomatic degenerative disc disease (DDD) with no more than Grade I spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic studies. The activL® artificial disc is implanted using an anterior retroperitoneal approach. Patients receiving the activL artificial disc should have failed at least six months of non-operative treatment prior to implantation of the device (FDA, 2015).

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 lumbar TDA device implantation (Bertagnoli, 2005, 2006; Delamarter, 2011; Siepe, 2006, 2012).

Definitions

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 arthroplasty (TDA): 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 equina 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:

Osteoporosis: A condition in which there is reduced bone strength (bone mass and bone quality) resulting in a higher risk of fractures.

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.

Pseudarthrosis: 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, spondyloptosis)
(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.

References

Peer Reviewed Publications:

  1. Aghayev E, Etter C, Barlocher C, et al. Five-year results of lumbar disc prostheses in the SWISSspine registry. Eur Spine J. 2014; 23(10):2114-2126.
  2. Andrade NS, Flynn JP, Bartanusz V. Twenty-year perspective of randomized controlled trials for surgery of chronic nonspecific low back pain: citation bias and tangential knowledge. Spine J. 2013; 13(11):1698-1704.
  3. Asghar FA, Hilibrand AS. The impact of the Spine Patient Outcomes Research Trial (SPORT) results on orthopaedic practice. J Am Acad Orthop Surg. 2012; 20(3):160-166.
  4. Bertagnoli R, Yue JJ, Fenk-Mayer A, et al. Treatment of symptomatic adjacent-segment degeneration after lumbar fusion with total disc arthroplasty by using the prodisc prosthesis: a prospective study with 2-year minimum follow up. J Neurosurg Spine. 2006; 4(2):91-97.
  5. Bertagnoli R, Yue JJ, Shah RV, et al. The treatment of disabling single-level lumbar discogenic low back pain with total disc arthroplasty utilizing the Prodisc prosthesis: a prospective study with 2-year minimum follow-up. Spine (Phila Pa 1976). 2005; 30(19):2230-2236.
  6. Blumenthal S, McAfee PC, Guyer RD, et al. A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part I: evaluation of clinical outcomes. Spine (Phila Pa 1976). 2005; 30(14):1565-1575; discussion E387-391.
  7. Brox JI, Nygaard ØP, Holm I, et al. Four-year follow-up of surgical versus non-surgical therapy for chronic low back pain. Ann Rheum Dis. 2010; 69(9):1643-1648.
  8. Brox JI, Reikerås O, Nygaard Ø, et al. Lumbar instrumented fusion compared with cognitive intervention and exercises in patients with chronic back pain after previous surgery for disc herniation: a prospective randomized controlled study. Pain. 2006; 122(1-2):145-155.
  9. Brox JI, Sørensen R, Friis A, et al. Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration. Spine (Phila Pa 1976). 2003; 28(17):1913-1921.
  10. Carreon LY, Glassman SD, Howard J. Fusion and nonsurgical treatment for symptomatic lumbar degenerative disease: a systematic review of Oswestry Disability Index and MOS Short Form-36 outcomes. Spine J. 2008; 8(5):747-755.
  11. Delamarter R, Zigler JE, Balderston RA, et al. Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement compared with circumferential arthrodesis for the treatment of two-level lumbar degenerative disc disease: results at twenty-four months. J Bone Joint Surg Am. 2011; 93(8):705-715.
  12. Deyo RA, Mirza SK, Martin BI, et al. Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. J Am Med Assoc. 2010; 303(13):1259-1265.
  13. Fairbank J, Frost H, Wilson-MacDonald J, et al. Randomized controlled trial to compare surgical stabilization of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilization trial. BMJ. 2005; 330(7502):1233.
  14. Fischer CR, Kim Y. Selective fusion for adolescent idiopathic scoliosis: a review of current operative strategy. Eur Spine J. 2011; 20(7):1048-1057.
  15. Försth P, Ólafsson G, Carlsson T, et al. A randomized, controlled trial of fusion surgery for lumbar spinal stenosis. N Engl J Med. 2016; 374(15):1413-1423.
  16. Fritzell P, Hägg O, Wessberg P, et al. 2001 Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group. Spine. 2001; 26(23):2521-2532.
  17. Garcia R, Yue JJ, Blumenthal S, et al. Lumbar total disc replacement for discogenic low back pain: two year outcomes of the activL multicenter randomized controlled IDE clinical trial. Spine (Phila Pa 1976). 2015; 40(24):1873-1881.
  18. Geisler FH, Blumenthal SL, Guyer RD, et al. Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in the literature: results of a multicenter, prospective, randomized investigational device exemption study of Charité intervertebral disc. J Neurosurg Spine. 2004; 1(2):143-154.
  19. Ghogawala Z, Dziura J, Butler WE, et al. Laminectomy plus fusion versus laminectomy alone for lumbar spondylolisthesis. N Engl J Med. 2016; 374(15):1424-1434.
  20. Gornet MF, Burkus JK, Dryer RF, Peloza JH. Lumbar disc arthroplasty with MAVERICK disc versus stand-alone interbody fusion: a prospective, randomized, controlled, multicenter investigational device exemption trial. Spine. 2011; 36(25):E1600-E1611.
  21. Guyer RD, McAfee PC, Banco RJ, et al. Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: five-year follow-up. Spine J. 2009; 9(5):374-386.
  22. Guyer RD, Pettine K, Roh JS, et al. Comparison of 2 lumbar total disc replacements: results of a prospective, randomized, controlled, multicenter Food and Drug Administration trial with 24-month follow-up. Spine (Phila Pa 1976). 2014; 39(12):925-931.
  23. Guyer RD, Pettine K, Roh JS, et al. Five-year follow-up of a prospective, randomized trial comparing two lumbar total disc replacements. Spine (Phila Pa 1976). 2016; 41(1):3-8.
  24. Hart R, Hermsmeyer JT, Sethi RK, et al. Quality and quantity of published studies evaluating lumbar fusion during the past 10 years: a systematic review. Global Spine J. 2015; 5(3):207-218.
  25. Hellum C, Johnsen LG, Storheim K, et al. Surgery with disc prosthesis versus rehabilitation in patients with low back pain and degenerative disc: two year follow-up of randomized study. BMJ. 2011; 342:d2786.
  26. Kwon B, Katz JN, Kim DH, Jenis LG. A review of the 2001 Volvo Award winner in clinical studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish lumbar spine study group. Spine (Phila Pa 1976). 2006; 31(2):245-249.
  27. Lu SB, Hai Y, Kong C, et al. An 11-year minimum follow-up of the Charite III lumbar disc replacement for the treatment of symptomatic degenerative disc disease. Eur Spine J. 2015; 24(9):2056-2064.
  28. Mannion AF, Brox JI, Fairbank JC. Comparison of spinal fusion and nonoperative treatment in patients with chronic low back pain: long-term follow-up of three randomized controlled trials. Spine J. 2013; 13(11):1438-1448.
  29. McAfee PC, Cunningham B, Holsapple G, et al. A prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITÉ artificial disc versus lumbar fusion: part II: evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical outcomes. Spine. 2005; 30(14):1576-1583.
  30. Mirza SK, Deyo RA. Systematic review of randomized trials comparing lumbar fusion surgery to nonoperative care for treatment of chronic back pain. Spine (Phila Pa 1976).  2007; 32(7):816-823.
  31. Noshchenko A, Hoffecker L, Lindley EM, et al. Long-term treatment effects of lumbar arthrodeses in degenerative disk disease: A systematic review with meta-analysis. J Spinal Disord Tech. 2015; 28(9):E493-521.
  32. Ohtori S, Koshi T, Yamashita M, et al. Surgical versus nonsurgical treatment of selected patients with discogenic low back pain: a small-sized randomized trial. Spine (Phila Pa 1976). 2011; 36(5):347-354.
  33. Park DK, An HS, Lurie JD, et al. Does multilevel lumbar stenosis lead to poorer outcomes: a subanalysis of the Spine Patient Outcomes Research Trial (SPORT) lumbar stenosis study. Spine (Phila Pa 1976). 2010; 35(4):439-446.
  34. Saltychev M, Eskola M, Laimi K. Lumbar fusion compared with conservative treatment in patients with chronic low back pain: a meta-analysis. NCT01780194. Int J Rehabil Res. 2014; 37(1):2-8.  
  35. Sansur CA, Reames DL, Smith JS, et al. Morbidity and mortality in the surgical treatment of 10,242 adults with spondylolisthesis. J Neurosurg Spine. 2010; 13(5):589-593.
  36. Shim CS, Lee SH, Shin HD, et al. CHARITE versus PRODISC-L: a comparative study of a minimum 3-year follow-up. Spine (Phila Pa 1976). 2007; 32(9):1012-1018.
  37. Siepe CJ, Heider F, Haas E, et al. Influence of lumbar intervertebral disc degeneration on the outcome of total lumbar disc replacement: a prospective clinical, histological, X-ray and MRI investigation. Eur Spine J. 2012; 21(11):2287-2299.
  38. Siepe CJ, Heider F, Wiechert K, et al. Mid- to long-term results of total lumbar disc replacement: a prospective analysis with 5- to 10-year follow-up. Spine J. 2014; 14(8):1417-1431.
  39. Siepe CJ, Mayer HM, Wiechert K, Korge A. Clinical results of total lumbar disc replacement with ProDisc II: three-year results for different indications. Spine (Phil Pa 1976). 2006; 31(17):1923-1932.
  40. Skold C, Tropp H, Berg S. Five-year follow-up of total disc replacement compared to fusion: a randomized controlled trial. Eur Spine J. 2013; 22(10):2288-2295.
  41. Smorgick Y, Park DK, Baker KC, et al. Single- versus multilevel fusion for single-level degenerative spondylolisthesis and multilevel lumbar stenosis: four-year results of the spine patient outcomes research trial.  Spine (Phila Pa 1976). 2013; 38(10):797-805.
  42. Vokshoor A. Spondylolisthesis, spondylolysis, and spondylosis. eMedicine. Orthopedic Topic 560. Omaha, NE:eMedicine.com: Updated February 3, 2007. Available at: http://www.emedicine.com/orthoped/topic560.htm. Accessed on December 4, 2017.
  43. Weinstein JN, Lurie JD, Tosteson TD, et al. Surgical compared with nonoperative treatment for lumbar degenerative spondylolisthesis. Four-year results in the Spine Patient Outcomes Research Trial (SPORT) randomized and observational cohorts. J Bone Joint Surg Am. 2009; 91(6):1295-1304.
  44. Weinstein JN, Lurie JD, Tosteson TD, et al. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis.  N Engl J Med. 2007; 356(22):2257-2270.
  45. Weinstein JN, Lurie JD, Tosteson TD, et al. Surgical vs. nonoperative treatment for lumbar disk herniation: The Spine Patient Outcomes Research Trial (SPORT) observational cohort. JAMA. 2006a; 296(20):2451-2459.
  46. Weinstein JN, Tosteson TD, Lurie JD, et al. Surgical vs. nonoperative treatment for lumbar disk herniation: The Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA. 2006b; 296(20):2441-2450.
  47. Zigler J, Delamarter R, Spivak JM, et al. Results of the prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential fusion for the treatment of 1-level degenerative disc disease. Spine (Phila Pa 1976). 2007; 32(11):1155-1162; discussion 1163.
  48. Zigler J. Five-year results of the ProDisc-L multicenter, prospective, randomized, controlled trial comparing ProDisc-L with circumferential spinal fusion for single-level disabling degenerative disk disease. Semin Spine Surg. 2012; 24(1):25-31.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Association of Neurological Surgeons (AANS). Guideline updates for the performance of fusion procedures for degenerative disease of the spine. J Neurosurg Spine. 2014; 21(1):1-139. Available at: http://thejns.org/toc/spi/21/1. Accessed on December 4, 2017.
  2. Centers for Medicare & Medicaid Services (CMS). Decision memo for lumbar artificial disc replacement (LADR) (CAG-00292R). Medicare Coverage Database. Baltimore, MD: CMS; August 14, 2007. Available at: http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=197&NcaName=Lumbar+Artificial+Disc+Replacement+(LADR)&DocID=CAG-00292R&id=197&bc=gAAAAAgACAAAAA%3d%3d&. Accessed on December 4, 2017.
  3. Chou R, Loeser JD, Owens DK, et al.; American Pain Society Low Back Pain Guideline Panel. Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an evidence-based clinical practice guideline from the American Pain Society. Spine (Phila Pa 1976). 2009; 34(10):1066-1077.
  4. Eck JC, Sharan A, Ghogawala Z, et al. American Association of Neurological Surgeons/Congress of Neurological Surgeons. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 7: lumbar fusion for intractable low-back pain without stenosis or spondylolisthesis. J Neurosurg Spine. 2014; 21(1):42-47. Available at: http://thejns.org/doi/pdf/10.3171/2014.4.SPINE14270. Accessed on December 4, 2017.
  5. Jacobs W, Van der Gaag NA, Tuschel A, et al. Total disc replacement for chronic back pain in the presence of disc degeneration. Cochrane Database Syst Rev. 2012;(9):CD008326. Available at:  http://www.cochrane.org/CD008326/BACK_total-disc-replacement-for-chronic-low-back-pain. Accessed on December 4, 2017.
  6. Jacobs W, Willems PC, van Limbeek J, et al. Fusion techniques for degenerative disc disease. Cochrane Database Syst Rev. 2011; (1):CD004958. Available at: http://www.cochrane.org/CD004958/BACK_fusion-techniques-for-degenerative-disc-disease. Accessed on December 4, 2017.
  7. Kreiner DS, Shaffer WO, Summers J, et al. North American Spine Society (NASS). Diagnosis and treatment of degenerative lumbar spinal stenosis. Revised 2011. Available at: https://www.spine.org/Documents/ResearchClinicalCare/Guidelines/LumbarStenosis.pdf. Accessed on December 4, 2017.
  8. McCrory DC, Turner DA, Patwardhan MB, et al. Spinal fusion for treatment of degenerative disease affecting the lumbar spine. Technology Assessment [draft]. Prepared for the Agency for Healthcare Research and Quality (AHRQ) by the Duke Evidence-based Practice Center. Rockville, MD: AHRQ; November 1, 2006. Available at: http://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id41ta.pdf. Accessed on December 4, 2017.
  9. North American Spine Society (NASS). NASS policy guidelines (multiple). Available at: https://www.spine.org/researchclinicalcare/qualityimprovement/clinicalguidelines.aspx. Accessed on December 4, 2017.
  10. Overdevest GM, Jacobs W, Vleggeert-Lankamp C, et al. Comparison of surgical techniques for the treatment of patients with lumbar stenosis. Cochrane Database Syst Rev. 2015; (3):CD010036. Available at: http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD010036.pub2/pdf/abstract. Accessed on December 4, 2017.
  11. Resnick DK, Choudhri TF, Dailey AT, et al.; American Association of Neurological Surgeons/Congress of Neurological Surgeons. Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 9: Fusion in patients with stenosis and spondylolisthesis. J Neurosurg Spine. 2005; (6):679-685.
  12. Resnick DK, Watters WC, Mummaneni PV, et al. American Association of Neurological Surgeons/Congress of Neurological Surgeons. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 10: lumbar fusion for stenosis without spondylolisthesis. J Neurosurg Spine. 2014; 21(1): 62-66. Available at: http://thejns.org/doi/pdf/10.3171/2014.4.SPINE14275. Accessed on December 4, 2017.
  13. Schoelles K, Reston J, Treadwell J, et al. Spinal Fusion and Discography for Chronic Low Back Pain and Uncomplicated Lumbar Degenerative Disc Disease. Health Technology Assessment. Prepared by the ECRI Institute for the Technology Assessment Program, Washington State Health Care Authority. Contract No. 6020-0017, Task Order No. 2. Olympia, WA: Washington State Health Care Authority. October 19, 2007.
  14. U.S. Food and Drug Administration 510(k) Premarket Notification Database. CHARITE Artificial Disc. Summary of Safety and Effectiveness. No. P040006. Rockville, MD: FDA. October 26, 2004. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf4/P040006B.pdf. Accessed on December 4, 2017.
  15. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Aesculap T-Space PEEK and XP Spinal System. Summary of Safety and Effectiveness. No. K151056. Rockville, MD: FDA. August 13, 2015. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf15/k151056.pdf. Accessed on December 4, 2017.
  16. U.S. Food and Drug Administration 510(k) Premarket Notification Database. PRODISC-L Total Disc Replacement. Summary of Safety and Effectiveness. No. P050010. Rockville, MD: FDA. August 14, 2006. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p050010. Accessed on December 4, 2017.
  17. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Aesculap activL artificial disc. Summary of Safety and Effectiveness.  No. P120024. Rockville, MD: FDA. June 11, 2015. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf12/P120024b.pdf.  Accessed on December 4, 2017.
  18. United States Preventive Services Task Force (USPSTF). Final Recommendation Statement Osteoporosis: Screening. April 2016. Available at: https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/osteoporosis-screening#table-1-osteoporosis-screening-recommendations-of-other-organizations. Accessed on December 5, 2017.
  19. Waddel G, Gibson J. Surgery for degenerative lumbar spondylosis. Cochrane Database Syst Rev. 2005;(4):CD001352. Available at: http://www.cochrane.org/CD001352/BACK_surgery-for-degenerative-lumbar-spondylosis. Accessed on December 4, 2017.
  20. Wang JC, Dailey AT, Mummaneni PV, et al. American Association of Neurological Surgeons/Congress of Neurological Surgeons. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 8: lumbar fusion for disc herniation and radiculopathy. J Neurosurg Spine. 2014; 21(1):48-53.
  21. Watters WC, Bono C, Gilbert T, et al. North American Spine Society (NASS). Diagnosis and treatment of degenerative lumbar spondylolisthesis. 2nd Edition. 2014. Available at: https://www.spine.org/Documents/ResearchClinicalCare/Guidelines/Spondylolisthesis.pdf. Accessed on December 4, 2017.
  22. Washington State Department of Labor and Industries. Guidelines for lumbar fusion (arthrodesis). Medical Treatment Guidelines. Olympia, WA: Washington State Department of Labor and Industries; 2009. Available at: http://www.lni.wa.gov/ClaimsIns/Files/OMD/MedTreat/LumbarFusion.pdf. Accessed on December 4, 2017.
Websites for Additional Information
  1. American Academy of Orthopedic Surgeons (AAOS). Website for relevant information. Available at: http://orthoinfo.aaos.org/topic.cfm?topic=A00348. Accessed on December 4, 2017.
  2. U.S. National Library of Medicine (NLM). Information on lumbar fusion and related procedures. Available at: http://vsearch.nlm.nih.gov/vivisimo/cgi-bin/query-meta?v%3Aproject=medlineplus&query=lumbar+fusion. Accessed on December 4, 2017.
  3. Wheeless CR, Nunley JA, Urbaniak JR, eds. Wheeless' Textbook of Orthopaedics. WheelessOnline.com. Brooklandville, MD: Data Trace Internet Publishing LLC; 2008. Available at: http://www.wheelessonline.com/. Accessed on December 4, 2017.
Index

activL Artificial Disc
Aesculap T-Space PEEK and XP Spinal System
Arthroplasty, Lumbar Total Disc (TDA)
Arthroplasty, Spinal
Artificial Intervertebral Disc Replacement (AID)
Charité Artificial Disc
InMotion Lumbar Artificial Disc System
Lumbar Artificial Intervertebral Disc (LAID)
Lumbar Fusion
ProDisc-L Total Disc Replacement
Total Disc Replacement (TDR)
Spinal Fusion

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.

History

Status

Date

Action

Revised

01/25/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. The criterion for lumbar TDA regarding osteoporosis as a contraindication was revised to delete reference to DEXA T scores and to indicate, “Bone density that does not meet the minimum level specified for the implanted device” with a note added regarding when DEXA scanning is indicated. The acronym “TDA” was removed from the title. References were updated. Appendix A was added which provides device specific definitions of inadequate bone density DEXA T scores for each FDA cleared TDA device.

Reviewed

11/02/2017

MPTAC review. The document header wording was updated from “Current Effective Date” to “Publish Date.” References were updated.

 

10/01/2017

Updated Coding section with 10/01/2017 ICD-10-CM diagnosis code changes and ICD-10-PCS procedure code changes, removed 0SG00A1, 0SG04A1, 0SG10A1, 0SG14A1, 0SG30A1, 0SG34A1 deleted 09/30/2017.

Revised

05/04/2017

MPTAC review. Minor typographical revisions were made in the Clinical Indications section. References were updated.

Reviewed

05/05/2016

MPTAC review. The Discussion and References sections were updated. Removed ICD-9 codes from Coding section.

Revised

05/07/2015

MPTAC review. The following revisions have been made:
• Title revised from Lumbar Fusion and Lumbar Artificial Intervertebral Disc (LAID) to Lumbar Fusion and Lumbar Total Disc Arthroplasty (TDA);
• Added limb weakness as an example of a progressive or severe neurologic deficit in the medically necessary criteria for lumbar fusion;
• Clarified 'Note' in medically necessary section addressing conservative medical management;
• Replaced the terminology, "Lumbar Artificial Intervertebral Disc (LAID)" with "Lumbar Total Disc Arthroplasty (TDA)" in the Description, Clinical Indications and throughout the document;
• Removed "progressive or severe neurologic deficits (for example, bowel or bladder dysfunction)" as an indication for lumbar TDA;
• Added "significant facet joint or zygohypophaseal joint changes" as contraindications for lumbar TDA;
• Moved medically necessary criteria addressing lumbar fusion for scoliosis to new guideline CG-SURG-47 Surgical Interventions for Scoliosis and Spinal Deformity;
The Discussion, Definitions and References sections were updated.

Revised

02/05/2015

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.

 

Appendix A

FDA Device Specific definitions of inadequate bone density as defined by DEXA T-scores:

Device

Contraindication or Precautions (T-score bone density)

activL Artificial Disc

DEXA bone mineral density T-score less than or equal to -1.0

CHARITE/InMotion

DEXA bone mineral density T-score less than or equal to -1.0

Pro-Disc L

DEXA bone density measured T-score less than -1.0

Sources:
activL Artificial Disc: https://www.accessdata.fda.gov/cdrh_docs/pdf12/P120024b.pdf. Accessed on December 13, 2017.
Charite/In Motion Artificial Disc: https://www.accessdata.fda.gov/cdrh_docs/pdf4/p040006b.pdf. Accessed on December 13, 2017.
ProDisc-L Artificial Disc: https://www.accessdata.fda.gov/cdrh_docs/pdf5/P050010C.pdf. Accessed on December 13, 2017.