Clinical UM Guideline


Subject:Lumbar Fusion and Lumbar Artificial Intervertebral Disc (LAID)
Guideline #:  CG-SURG-33Current Effective Date:  04/15/2014
Status:RevisedLast Review Date:  02/13/2014

Description

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 one or more vertebral discs 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.

For information regarding other spinal procedures, 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: 

  1. The individual has symptomatic spondylolisthesis confirmed on x-ray and a), b), or c) 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);
      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 and severe degenerative scoliosis with:
    1. Persistent severe axial pain, persistent weakness with functional impairment, persistent neurogenic claudication, or persistent radicular pain, unresponsive to at least 3 months of conservative medical therapy; or
    2. Deformity greater than 50 degrees with functional impairment; 
      OR
  6. The individual has symptomatic lumbar pseudarthrosis and it has been at least 6 months since the initial fusion and ALL of the following:
    1. The pseudoarthrosis 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
  7. 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).

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)

Medically Necessary:

Lumbar artificial intervertebral disc (LAID) implantation is considered medically necessary when ALL of the following are met:

  1. Spondylolisthesis with 1 or more of the following:
    1. Progressive or severe neurologic deficits (for example, bowel or bladder dysfunction); or
    2. Adults (age greater than 18) with persistent and significant symptoms, despite an adequate trial of at least 6 months of conservative care with low-grade spondylolisthesis demonstrated on x-ray;  AND
  2. Degenerative disc disease is limited to the single spinal level at which the LAID is planned;  AND
  3. An FDA approved LAID 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 an LAID device;  AND
  5. The individual is skeletally mature;  AND
  6. There are no contraindications to lumbar AID 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. Osteopenia or osteoporosis (defined as DEXA bone density measured T-score less than -1.0); 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.

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.

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 
22533Arthrodesis, lateral extracavitary technique, including minimal discectomy to prepare interspace (other than for decompression); lumbar
22534Arthrodesis, lateral extracavitary technique, including minimal discectomy to prepare interspace (other than for decompression); thoracic or lumbar, each additional vertebral segment
22558Arthrodesis, anterior interbody technique, including minimal discectomy to prepare interspace (other than for decompression); lumbar
22585Arthrodesis, anterior interbody technique, including minimal discectomy to prepare interspace (other than for decompression); each additional interspace
22612Arthrodesis, posterior or posterolateral technique, single level; lumbar (with lateral transverse technique, when performed)
22614Arthrodesis, posterior or posterolateral technique, single level; each additional vertebral segment
22630Arthrodesis, posterior interbody technique, including laminectomy and/or discectomy to prepare interspace (other than for decompression), single interspace; lumbar
22632Arthrodesis, posterior interbody technique, including laminectomy and/or discectomy to prepare interspace (other than for decompression); each additional interspace
22633Arthrodesis, 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
22634Arthrodesis, 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
22857Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression), single interspace, lumbar
22862Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, single interspace; lumbar
0163TTotal disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression), each additional interspace, lumbar
0165TRevision including replacement of total disc arthroplasty (artificial disc), anterior approach, each additional interspace, lumbar
  
ICD-9 Procedure[For dates of service prior to 10/01/2014]
81.05Dorsal and dorsolumbar fusion of the posterior column, posterior technique
81.06Lumbar and lumbosacral fusion of the anterior column, anterior technique
81.07Lumbar and lumbosacral fusion of the posterior column, posterior technique
81.08Lumbar and lumbosacral fusion of the anterior column, posterior technique
81.36Refusion of lumbar and lumbosacral spine, anterior column, anterior technique
81.37Refusion of lumbar and lumbosacral spine, posterior column, posterior technique
81.38Refusion of lumbar and lumbosacral spine, anterior column, posterior technique
84.65Insertion of total spine disc prosthesis, lumbosacral
84.68Revision or replacement of artificial spinal disc prosthesis, lumbosacral
  
ICD-9 Diagnosis[For dates of service prior to 10/01/2014]
 All diagnoses
  
ICD-10 Procedure[For dates of service on or after 10/01/2014] 
0SG0070-0SG04ZJLumbar 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]
0SG1070-0SG14ZJLumbar 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]
0SG3070-0SG34ZJLumbosacral 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]
0SR20JZReplacement of lumbar vertebral disc with synthetic substitute, open approach
0SR40JZReplacement of lumbosacral disc with synthetic substitute, open approach
0SW20JZ-0SW24JZRevision of synthetic substitute in lumbar vertebral disc [by approach; includes codes 0SW20JZ, 0SW23JZ, 0SW24JZ]
0SW40JZ-0SW44JZRevision of synthetic substitute in lumbosacral disc [by approach; includes codes 0SW40JZ, 0SW43JZ, 0SW44JZ]
   
ICD-10 Diagnosis[For dates of service on or after 10/01/2014] 
 All diagnoses
  
Discussion/General Information

Although chronic low back pain does not always have a precisely identifiable cause, the following conditions are attributed to persistent low back pain:  degenerative disc disease (DDD), muscle strain, skeletal trauma, infection and tumor.  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, standing for any extended period of time).  

Lumbar Fusion: 

Spinal fusion has been the established 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, spinal fusion alters the biomechanics of the back, potentially leading to premature disc degeneration at adjacent levels of the spine.  Complications following spinal fusion 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 lumbar fusion surgery may improve function and pain for individuals with low back pain attributed to DDD.  However, to date, the published evidence and systematic reviews, in favor of lumbar/spinal fusion 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). 

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 four-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), spinal fusion 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 low back pain has been intractable to best medical management (Weinstein, 2009).  Treatment of spondylolisthesis with spinal fusion 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 fusion.  Complications rates in subjects undergoing fusion versus those undergoing decompression alone were not significantly different.  It is generally understood in the practice community that degenerative symptomatic spondylolisthesis is treated with spinal fusion due to the reported risks of deformity progression and chronic pain in the majority of those treated without fusion (Sansur, 2010; Weinstein, 2009).

In 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 low back pain.  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 one level with FDA-specified grades of spondylolisthesis present at the involved spinal level and evidence of at least six 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 two-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 two 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 five-year study, of which 160 subjects completed the five-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 five-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 0.8mm in those implanted with CHARITE at L4-L5 vs. L5-S1, respectively, and 0.1mm in BAK recipients.  The investigators concluded that the five-year results were consistent with the two-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 two-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.  Two hundred thirty-six subjects were treated and followed up for 5 years; 161 total disc replacements (TDR) and 75 fusions had been performed.  The primary outcome was a 10-component success end point.  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 (Delamarter, 2011; Bertagnoli, 2005, 2006; Siepe, 2006, 2012).

Definitions

Arthrodesis (also known as spinal fusion):  This surgical procedure involves the joining of two or more lumbar vertebrae (discs) 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.

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).

Intervertebral disc:  The soft tissues located between each vertebra; these discs act as cushions between the vertebrae during normal motion.

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.

References

Peer Reviewed Publications:

  1. 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.
  2. 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.
  3. 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. 2005; 30(19):2230-2236.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. Fischer CR, Kim Y. Selective fusion for adolescent idiopathic scoliosis: a review of current operative strategy. Europ Spine J. 2011; 20(7):1048-1057.
  12. 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.
  13. 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.
  14. 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.
  15. 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.
  16. 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 randomised study.  BMJ. 2011; 342:1-11.
  17. 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.
  18. 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.
  19. 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.
  20. 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.
  21. 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.
  22. Shim CS, Lee SH, Shin HD, et al. CHARITE versus PRODISC-L: A comparative study of a minimum 3-year follow-up. Spine. 2007; 32(9):1012-1018.
  23. 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.
  24. 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. 2006; 31(17):1923-1932.
  25. 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.
  26. Vokshoor A. Spondylolisthesis, spondylolysis, and spondylosis. eMedicine. Orthopedic Topic 560. Omaha, NE:eMedicine.com: Updated June 30, 2004. Available at: http://www.emedicine.com/orthoped/topic560.htm. Accessed on January 19, 2014.
  27. 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.
  28. 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.
  29. 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.
  30. 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.
  31. 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. 2007; 32(11):1155-1162; discussion 1163.
  32. 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; 24:25-31.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Blue Cross Blue Shield Association (BCBSA), Technology Evaluation Center (TEC). Artificial lumbar disc replacement. TEC Assessment Program. Chicago, IL: BCBSA; 2007; 22(2).
  2. Blue Cross and Blue Shield Association (BCBSA), Technology Evaluation Center (TEC). Artificial lumbar disk arthroplasty for treatment of degenerative disk disease of the lumbar spine. TEC Assessment Program.  Chicago, IL:BCBSA; 2013; In press.
  3. California Technology Assessment Forum (CTAF).  Artificial Disc Replacement for Degenerative Disc Disease of the Lumbar Spine.  A Technology Assessment. San Francisco, CA: CTAF; February 28, 2007.  Available at:  http://www.ctaf.org/assessments/artificial-disc-replacement-degenerative-disc-disease-lumbar-spine.  Accessed on January 19, 2014.
  4. 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 January 19, 2014.
  5. 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. 2009; 34(10):1066-1077.
  6. International Society for Advancement of Spine Surgery (ISASS). Policy Statement on Lumbar Spinal Fusion Surgery. July 15, 2011.  Available at: http://www.isass.org/public_policy/2011-07-15_policy_statement_lumbar_surgery.html.  Accessed on January 19, 2014.
  7. 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 of Systematic Reviews. February 28, 2013; Issue 9. Art. No.: CD008326.  Available at:  http://summaries.cochrane.org/CD008326/total-disc-replacement-for-chronic-low-back-pain.  Accessed on January 19, 2014.
  8. 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 March 31, 2014.
  9. 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.hhs.gov/determinationprocess/downloads/id41ta.pdf.  Accessed on January 19, 2014.
  10. National Institute for Clinical Excellence (NICE).  Prosthetic intervertebral disc replacement in the lumbar spine (IPG306).  Issued:  July 2009.  Available at:  http://publications.nice.org.uk/prosthetic-intervertebral-disc-replacement-in-the-lumbar-spine-ipg306.  Accessed on January 19, 2014.
  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 7: Intractable low-back pain without stenosis or spondylolisthesis.  J Neurosurg Spine. 2005a; 2(6):670-672.
  12. 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. 2005b;(6):679-685.
  13. Schoelles K, Reston J, Treadwell J, et al. Spinal fusion and discography in chronic 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. Available at: http://www.hca.wa.gov/hta/documents/spinal_fusion_discography_final_101907.pdf. Accessed on January 19, 2014.
  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:  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=p040006.  Accessed on January 19, 2014.
  15. 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:  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P050010.  Accessed on January 19, 2014.
  16. Watters WC, Bono C, Gilbert T, et al.  North American Spine Society (NASS).  Diagnosis and Treatment of Degenerative Lumbar Spondylolisthesis.  2008.  Available at: https://www.spine.org/Documents/ResearchClinicalCare/Guidelines/Spondylolisthesis.pdf.  Accessed on March 31, 2014.
  17. Waddel G, Gibson J.  Surgery for degenerative lumbar spondylosis . Cochrane Database of Systematic Reviews. 2008; Issue 4. Art. No.: CD001352.  Available at:  http://summaries.cochrane.org/CD001352/surgery-for-degenerative-lumbar-spondylosis.  Accessed on January 19, 2014.
  18. 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 January 19, 2014.
Websites for Additional Information
  1. American Academy of Orthopedic Surgeons (AAOS).  Web site for relevant information.  Available at:  http://orthoinfo.aaos.org/topic.cfm?topic=A00348.  Accessed on January 19, 2014.
  2. North American Spine Society (NASS). Know your back. Available at: http://www.knowyourback.org/Pages/Default.aspx.  Accessed on January 19, 2014.
  3. 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 January 19, 2014.
  4. 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 January 19, 2014.
Index

Artificial Intervertebral Disc Replacement (AID)
Arthroplasty, Spinal
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

Revised02/13/2014Medical Policy & Technology Assessment Committee (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.
New05/09/2013MPTAC review. Initial document development.