This document describes the use of lumbar and cervical artificial intervertebral discs to treat degenerative disc disease (DDD) of the spine.

Investigational and Not Medically Necessary:

Lumbar artificial intervertebral discs are considered investigational and not medically necessary.

Cervical artificial intervertebral discs are considered investigational and not medically necessary.

Lumbar artificial discs:

LUMBAR ARTIFICIAL DISCS:

CHARITÉ^® Artificial Disc (DePuy Spine, Inc., Raynham, MA):
In October 2004, the U.S. Food and Drug Administration (FDA) granted Premarket Approval (PMA) for the CHARITÉ  Artificial Disc, stating that the device is indicated for spinal arthroplasty in skeletally mature individuals with degenerative disc disease (DDD) at the L4-L5 interspace or the L5-S1 interspace. DDD is defined as discogenic back pain with degeneration of the disc confirmed by the medical history and radiographic studies. The approval was based in part on the results of a trial that randomized 304 participants with degenerative disc disease of the lumbar spine to undergo either implantation with a CHARITÉ  Artificial Disc or undergo lumbar fusion using a BAK^® Interbody Fusion System. Those receiving the artificial disc had an overall composite success rate of 63%, and those receiving the BAK cage had a success rate of 53%. This met the specified non-inferiority criteria with a p-value of .0001.  Although the CHARITÉ  Artificial Disc had a higher success rate than the BAK cage, this difference would not have met traditional criteria for a superiority trial (Blumenthal, 2005; McAfee, 2005).

This randomized controlled trial has several methodological issues that make it difficult to interpret the results.  The first concern is that the analysis showed non-inferiority compared to BAK fusion using the composite measure of success, but did not show statistically significant superiority in most outcome measures. A trial which is designed and analyzed as a non inferiority trial usually establishes a less stringent standard for demonstrating efficacy than a standard clinical trial. Such trials are often employed when there is some margin of acceptable inferiority of a new technology in its principal outcome that is offset by some other advantage, such as less morbidity, less invasiveness, better acceptability to individuals, or lower cost. In the case of the CHARITÉ  Artificial Disc, there are no offsetting advantages that are immediately evident or proven, as it is simply proposed to provide greater relief of back pain. The CHARITÉ^® Artificial Disc might provide greater flexibility than conventional fusion, but there is no firm evidence to show this.

The second concern is that the lack of a prespecified analysis plan, unexplained closure of the data base before all participants reached completion, and lack of intent-to-treat analysis may cast some doubt on the analysis.

At the time of FDA approval, the long-term safety and effectiveness of the CHARITÉ  Artificial Disc was unknown, therefore, the FDA approval of the CHARITÉ^® Artificial Disc was contingent upon a five (5) year post-approval study of 201 randomized investigational subjects; 67 training investigational subjects, and 98 control subjects. The primary endpoint of the study would evaluate overall success, defined as:

• improvement of at least 15 points in the Oswestry Disability Index (ODI) score compared to the baseline score;
• no device failures requiring revision, reoperation, or removal;
• absence of major complications, defined as major vessel injury or major neurological deterioration (e.g., nerve root injury);
• maintenance or improvement in neurological status vs. baseline, with no permanent neurological deficits compared to baseline status.

In 2009, Guyer and colleagues published the 5 year follow-up multicenter study of the participants in the initial study.  Of the 375 individuals who initially participated, only 133 completed the 5 year trial. Of the 14 centers initially participating, 6 declined participation in the 5 year follow-up. As in the initial study, the authors reported 'non inferiority' of the CHARITÉ Artificial Disc compared to the BAK^® lumbar fusion device, a largely abandoned device. This comparison suggests a methodological bias against fusion. Finally, due to the large amount of participants lost to follow-up, the authors based outcome analysis on statistical models rather than actual clinical data. The long term utility of the CHARITÉ  Artificial Disc remains unclear.

PRODISC-L^® (Synthes Spine, Inc., West Chester, PA):
The PRODISC-L  received FDA PMA on August 15, 2006. This device, like the CHARITÉ  consists of two metal endplates with a plastic inlay. The FDA labeled indications for the PRODISC-L  device for spinal arthroplasty are for those who:

• are skeletally mature;
• have degenerative disc disease (DDD) at one level in the lumbar spine (from L3-S1);
• have no more than Grade 1 spondylolisthesis at the involved level;
• have had no relief from pain after at least six months of non-surgical treatment.

The PMA is contingent upon a five year post approval study to evaluate long-term safety and effectiveness of the PRODISC-L .

Bertagnoli and colleagues (2006) reported in a study (n=22) that the use of PRODISC-L  device for lumbar total disc arthroplasty in individuals older than 60 years of age reduces chronic low back pain (LBP) and improves clinical functional outcomes, but the judicious use of artificial disc replacement in this age group is recommended. Until further findings are reported, the authors cautiously recommend the use of artificial disc replacement in the treatment of chronic discogenic low back pain in those older than age 60 years where bone quality is adequate in the absence of circumferential spinal stenosis.

Chung and colleagues (2006) studied the clinical and radiographic outcomes of 36 consecutive participants who underwent lumbar total disc replacement (TDR) using PRODISC-L and the factors associated with a better clinical outcome after a 2-year minimum follow-up. At the time of the latest follow-up, the success rate was 94% of 36 individuals according to the criteria of the FDA. They concluded that the PRODISC-L^® showed excellent clinical and radiographic outcomes without any significant complication. However, future efforts need to be directed toward the evaluation of a larger number of individuals with longer follow-up.

In a longitudinal prospective study (n=41), Leivseth (2006) found that the rotational range of motion of segments instrumented with a PRODISC-L  prosthesis was low, especially at L4-L5 and L5-S1. In the majority of cases, it amounted to less than 45% of the normal range and that virtually no improvement occurred between 1 and 2 years after surgery.

Freeman and colleagues (2006), in a systematic review of the published literature for the CHARITÉ^® and PRODISC-L   devices, found that to date, no study has shown total disc replacement to be superior to spinal fusion in terms of clinical outcome. Additionally, the long-term benefits of artificial disc replacement in preventing adjacent level disc degeneration have yet to be realized and the complications of artificial disc replacement may not be known for many years. Larger, well designed prospective randomized controlled trials with longer follow-up are required before widespread use of this technology.

Zigler and colleagues (2007) reported a prospective, randomized, multicenter, FDA investigational device exemption (IDE) industry sponsored clinical trial. Two hundred thirty six participants (161 investigational; 75 control) were treated with either the PRODISC-L or circumferential fusion at one spinal level. Participants were blinded until after surgery. Clinical evaluations occurred after surgery at 6 weeks, 3, 6, 12, 18, and 24 months. Evaluation at each visit included patient self-assessments, physical and neurologic examinations, and radiographic evaluation. The study was a non inferiority design. Alternative outcome criteria was required by the FDA: 1) ODI Point Analysis: The FDA success criterion required a greater than or equal to 15 point improvement. Using this definition, 67.8% of investigational and 54.9% of control patients were successful, and the investigational group was statistically superior to the control group at 24 months (p = 0.0449). 2) Radiographic Flexion-Extension ROM Analysis: By the FDA definition, ROM success required greater motion at 24 months than at preoperative baseline for investigational patients. Using this analysis, 89.5% of the investigational participants were clinically successful. 3) Overall Success: Using the FDA definition, 53.4% of investigational and 40.8% of control participants were successful, with a statistically significant difference favoring the investigational group (p = 0.0438). This study is part of the long term study contingency of the FDA PMA approval.

In 2009, the American Pain Society's (APS) practice guidelines provided a recommendation of "insufficient evidence" to adequately evaluate long-term benefits and harms of vertebral disc replacement for low back pain.

In a 2010 review, van den Eerenbeemt and colleagues performed a literature review for the artificial lumbar disc. Devices included the review were the CHARITE, PRODISC-L, Maverick™ (Medtronic Sofamor Danel, Memphis, TN), FlexiCore™ Intervertebral Disc (Stryker Spine, Allendale, NJ) and AcroFlex^® (DePuy Acromed, Raynham, MA). Studies included prospective cohorts having 20 or more participants and controlled studies. Primary outcomes considered relevant were pain intensity e.g. visual analogue scale (VAS), functional status, e.g. Roland Morris Disability Scale and Oswestry Scale (ODI). Risk of bias was assessed in the qualifying studies. Both CHARITE and PRODISC-L studies were based on non inferiority as compared to currently accepted surgical treatment. The reviewers found that there is low quality evidence that the CHARITE is non-inferior to the BAK cage surgical procedure at the 2-year follow up for the primary outcome measures. For the 5-year follow up, the same conclusion is supported only by very low quality evidence. For the PRODISC-L, there is very low quality evidence for contradictory results on the primary outcome measures when compared with anterior lumbar circumferential fusion. The authors concluded that high quality randomized controlled trials with relevant control group with long-term follow up are needed to evaluate the effectiveness and safety of these devices.

Delamarter and colleagues (2011) examined use of the PRODISC-L compared with fusion at two contiguous vertebral levels from L3 to S1. At 24 months, eighty-seven (58.8%) of 148 patients in the total disc replacement group and thirty-two (47.8%) of sixty-seven patients in the arthrodesis group were evaluable based on the FDA required criteria. The criteria were as follows: 1) Greater than or equal to 15 % improvement ODI compared to baseline. 2) Improvement in SF-36 PCS compared with baseline. 3) Neurological status improved or maintaind from baseline. 4) No secondary surgical procedures to remove or modify the total disc replacement implant or arthrodesis implant/site. 5) No subsidence greater than 3mm. 6) No migration greater than 3 mm. 7) No radiolucency/loosening. 8) No loss of disc height greater than 3mm. 9) Total disc replacement-range of motion improved or maintained from baseline. 10) Arthrodesis- no motion less than 10 degrees angulation, total for 2 levels combined on flexion and extension. At twenty-four months, clinical significance in favor of the total disc replacement group was shown in the ODI, Short Form Health Survey (SF-36) and secondary surgical procedure group. The composite end point and neurologic success outcomes were not clinically significant. Radiographic and range of motion outcomes were significant in favor of the arthrodesis group. The authors concluded that in this relatively short study, 2 level PRODISC-L  replacement offers an alternative to 2 level arthrodesis.

CERVICAL ARTIFICIAL DISCS:

PRODISC-C^®  (Synthes Spine, Inc., West Chester, PA):
The PRODISC-C  is used for disc replacement in the cervical spine and received FDA PMA in December 2007. The following are the FDA labeled indications for use of the PRODISC -C in those who:

• Are skeletally mature;
• Have intractable symptomatic cervical disc disease (SCDD);
• Need reconstruction of the disc from C3-C7 following single-level discectomy;
• Have failed at least six weeks of non-operative treatment prior to implantation; 
• PRODISC-C is implanted via an open anterior approach.

The PMA is contingent upon a seven year post approval study to evaluate long-term safety and effectiveness of the PRODISC-C .

Nabhan (2007), studied anterior cervical discectomy fusion (ACDF) compared to PRODISC -C prosthesis. Thirty-three participants with refractory symptomatic cervical soft disc herniation were randomized into two treatment groups; one group was treated with ACDF and the other group was treated with a cervical disc prosthesis. Radiostereometric analysis (RSA) was used to quantify intervertebral motion immediately as well as 3, 6, 12 and 24 weeks postoperatively. Of the 33 participants, 8 were excluded during first RSA measurement due to some markers being obscured. Additional clinical results were judged using the visual analogue scale (VAS) and neuro-examination. The study results found that cervical spine segmental motion decreased over time in the presence of disc prosthesis or ACDF. However, the loss of segmental motion is significantly higher in the ACDF group, when looked at 3, 6, 12 and 24 weeks after surgery. Significant pain reduction was observed in the neck and arm postoperatively, without significant difference between both groups (P ≥0.05). The authors acknowledged that the study was small and that larger studies with longer follow-up are warranted. 

Murrey (2009) reported a 2-year follow-up to determine the safety and efficacy of PRODISC-C in comparison with ACDF. Two hundred nine individuals with symptomatic cervical disc disease were included and received either the PRODISC -C or ACDF. One hundred three participants received the PRODISC -C implant and 106 were treated with fusion; participants were blinded to intervention until following surgery. Follow-up between 6 weeks and 2 years was reported to be 85% (178 participants) in the summary of safety and effectiveness data. Reasons for the loss to follow-up were not described. Non-inferiority was achieved for the FDA-defined combined endpoint of neurologic examination, neck disability index, adverse events, and device success, with 72% of PRODISC^®-C and 68% of fusion individuals achieving success in all 4 component endpoints. Clinical outcomes at 24 months' follow-up were reported to be similar in the PRODISC -C and fusion groups for the following components: neurological success (91% vs. 88%, respectively), neck disability index (21.4 vs. 20.5 points), reduction in Visual Analogue Scale (VAS) pain scores (e.g., 46 mm vs. 43 mm), and participant satisfaction (83 mm vs. 80 mm). Limitations of this study are the 2-year follow-up precluding conclusions about long-term device performance, adjacent disc degradation and the possibility of revision surgery.

Delamarter and colleagues (2010) reported the results from the 2 year  prospective, randomized, multicenter IDE trial of the PRODISC -C versus ACDF with 4 year follow-up including continued access (CA) individuals. Two hundred nine (n=103 PRODISC -C; n= 106 ACDF) and an additional 136 CA individuals were treated at 13 sites. From August 2003 to October 2004, 209 randomized individuals are continuing follow up for 7 years. After closure of randomized enrollment in 2004, an additional series of 136 CA patients had PRODISC -C disc replacement surgery from March 2005 to January 2008. Evaluations included NDI, VAS for pain/satisfaction, radiographic and physical/neurologic examinations. VAS pain and NDI score improvements from baseline were significant for all participants (p ≤ .0001) but did not differ among groups. VAS neck and arm pain intensity assessments indicated statistically significant improvement from preoperative scores regardless of treatment (p ≤.0001), however, the scores varied during the interval evaluations. Likewise in the SF-36,  regardless of treatment and at all time points, there was a statistically significant improvement in SF-36 scores from baseline (p ≤ .0016). Radiography and secondary surgeries were reported showing that the PRODISC -C and CA groups having better outcomes. A limitation to this study is participant accountability. No information regarding those lost to follow-up was given. The authors concluded that these preliminary data at 4 years show that both TDR and ACDF are viable surgical options for participants with symptomatic cervical disk disease and that both groups continue to show good clinical results at longer-term follow-up.

PRESTIGE^® Cervical Disc System (Medtronic Sofamor Danek, Inc., Memphis, TN):
The PRESTIGE  Cervical Disc System received FDA PMA on July 16, 2007. This device consists of two main metal pieces, superior (upper) and inferior (lower) parts that move with respect to one another by a ball and trough mechanism. It is indicated in skeletally mature individuals for reconstruction of the disc from C3-C7 following single-level discectomy for intractable radiculopathy and/or myelopathy. The approval is also subject to a 7-year post-approval study to evaluate the long term safety and effectiveness of the PRESTIGE  Cervical Disc.

In a FDA IDE clinical trial, Mummaneni and colleagues (2007) conducted an unblinded randomized controlled study (RCT) of individuals with single-level cervical DDD and radiculopathy. Participants at 32 medical sites were randomly assigned to one of two treatment groups: 276 in the investigational group and 265 in the control group. The investigational group underwent anterior cervical discectomy and decompression and artificial intervertebral disc arthroplasty (AIDA) with the PRESTIGE  Cervical Disc. The control group underwent an allograft anterior cervical discectomy and fusion (ACDF). Eighty percent of the arthroplasty-treated group (n=223) and 75% of the control group (n=198) completed clinical and radiographic follow-up examinations at routine intervals for 2 years after surgery. The study groups were well matched demographically and appropriate for surgical fusion. Historically, complete fusion has been associated with a 98% success rate in ACDF control cases. The fusion success rate would be a difficult endpoint for cervical arthroplasty to exceed supporting the rationale for a non inferiority study design rather than a superiority design.

Although the trial has positive aspects, some issues may cloud the conclusions:

• The trial was unblinded, which could introduce bias. Blinding would also contribute to better assessment of pain.
• The study reported that 4% of the cohort withdrew because they were dissatisfied with their treatment group.
• The investigational group reported better neurological success, however the investigators provided no detail how the neurological status was measured and evaluated.

Overall, the study failed to demonstrate superiority for the neck disability index (NDI), since scores were statistically significant only at the three month follow-up. The study provided outcome information for two years, which precludes conclusions about long term device performance and adjacent disc degeneration. A critical issue not addressed in the study was the difficulty in revising a failed implant.

Burkus and colleagues (2010) reported a subset analysis of the the initial FDA IDE multicenter study (Mummaneni,  2007). This analysis reported outcomes for the first 271 or 50% of the participants to reach 5 postoperative years. Because of the loss to follow-up rates at 60 months, the authors used the Last Observation Carried Forward (LOCF) method, i.e. for any patient who did not have 60-month outcome data, the last available outcome value was carried to 60 months for both groups. While the authors reported promising data for the PRESTIGE  Cervical Disc no conclusions can be drawn from a 50% participant outcome.

BRYAN^® Cervical Disc System (Medtronic Sofamor Danek, Inc., Memphis, TN):
The BRYAN  Cervical Disc System received FDA PMA on May 12, 2009. The FDA labeling states that this device is indicated in skeletally mature individuals for reconstruction of the disc from C3-C7 following single-level discectomy for intractable radiculopathy and/or myelopathy that is refractory to 6 weeks of conservative therapy. The PMA is contingent upon a 10 year post approval study (PAS) to evaluate longer term safety and effectiveness. The BRYAN  Cervical Disc is a composite-type artificial disc designed with a low friction, wear resistant, elastic nucleus with two anatomically shaped metal plates. A flexible membrane forms a sealed space and contains a lubricant to reduce friction and wear and tear.

Sasso and colleagues (2007) conducted a prospective, randomized study comparing the functional outcome of single level cervical disc replacement with the BRYAN  Cervical Disc System to an anterior cervical fusion. One hundred ten participants were enrolled and results of 99 participants were reported at 2 years. Clinical outcomes for neck and arm pain were measured using Neck Disability Index (NDI), Visual Analog Scale (VAS) and SF-36. Motion at the operative level was imaged by digital radiographs and assessed by blinded trained observers using quantitative motion analysis software (QMA, Medical Metrics). The mean NDI before surgery was not statistically different between groups: 47 (BRYAN) and 49 (control). At the 2-year follow-up, NDI for the Bryan group was 11 and the control group was 20 (p = 0.005). The mean arm pain VAS before surgery was 70 (BRYAN ) and 71 (control). At 2-year follow-up, the average arm pain VAS for the BRYAN  group was 14 and control 28 (p = 0.014). The mean neck pain VAS before surgery was 72 (BRYAN^®) and 73 (control); 2-year follow-up: 16 (BRYAN) and 32 (control) (p = 0.005). SF-36 scores: Physical component -- before surgery BRYAN^® 34 and control 32; at 24 months: BRYAN  51 and control 46 (p = 0.009). More motion was retained after surgery in the disc replacement group than the plated group at the treated level.  The disc replacement group retained an average of 7.9 degrees of flexion-extension at 24 months. In contrast, the average range of motion in the fusion group was 0.6 degrees at 24 months. Although there are statistically significant differences between the 2 groups at the 24 month assessment, the authors also stated:

The FDA IDE studies of arthroplasty versus ACDF will eventually provide these important long-term data for us to understand the appropriate indications for this new technique…Although far from being an accepted standard, the concept of artificial disc replacement is gradually becoming a reality. The possibility of being able to minimize adjacent segment degeneration is exciting; however, much more intermediate and long-term outcome-based data are going to be necessary to prove that this technology supersedes the current gold standard of anterior fusion. Biomechanical studies demonstrate that disc replacement creates less adjacent level strain than fusion. Hopefully, with time, long-term studies will prove that this correlates to a lower incidence of adjacent level degeneration. Recent clinical reports show promising early data suggesting that artificial disc replacement is comparable to fusion at least in the short-term. Wear studies suggest that there may be less potential for aseptic loosening than in large joint arthroplasty, although the reality of this will only be borne out with more follow-up time. While early reports of success in the United States with the TDR suggest that the intended effects are being achieved, the final results of arthroplasty with these devices and of cervical arthroplasty are pending the outcomes of long-term studies.

Heller (2009) in a prospective, randomized, controlled multicenter (30 sites) trial studied 242 participants who received the BRYAN  cervical disc and 221 participants who received ACDF. At 24 months, 230 in the BRYAN^® group and 194 in the ACDF group were available for evaluation. Both groups had statistically significant reductions in the NDI at 24 months, however, the BRYAN  group had a higher proportion of a greater than 15 point reduction in NDI than the ACDF group. Both groups had reductions in neck and arm pain at each follow-up interval over 24 months; however the BRYAN  group improvement was greater in all postoperative intervals. SF-36 and neurologic success results at 24 months were similar for both groups and not statistically significant. Overall success was 82.6% in the BRYAN  group and 72.7% in the ACDF group. The difference of 9.9% was statistically significant. Range of motion ROM) increased only slightly in the BRYAN  group. The authors stated that ROM values measured radiographically can be influenced by anatomy, technique, interpretation or the individual's motivation and may not indicate mechanical failure of the device. In sum, the authors pointed out a weakness in this study. One hundred seventeen individuals declined participation after randomization. One reason for  withdrawal was dissatisfaction with the assigned group. Another limitation of the study is the short follow up period. Long term studies are needed to evaluate artificial disc devices' mechanical integrity at treated and adjacent levels.

Garrido and colleagues (2010) reported a 48 month, single site, follow-up on a randomized study of 47 participants as part of a multicenter study of the BRYAN cervical disc. Thirty-eight participants were available at 48 months. BRYAN cervical disc (n= 18) were compared to those having anterior cervical dissection and fusion (ACDF) (n=20). The BRYAN disc compared favorably with ACDF for functional data analysis. Reoperation for adjacent disc disease was necessary for 1 person in the BRYAN group and 3 in the ACDF group. The authors noted that although the outcomes supported the BRYAN disc, the limitations of this study were the low number of participants to demonstrate a statistical difference.   

The FDA actively tracks devices whose approvals are contingent upon a post approval long term study.

Degenerative disc disease (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, e.g. cervical, 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 is the natural aging process although various associated factors may accelerate the process. Not all individuals with disc degeneration are symptomatic with pain. Spinal fusion is a common surgical approach for DDD. The procedure removes the damaged areas of the disc and fuses the remaining vertebral segment, eliminating the motion between adjacent vertebral segments, and thus reducing the pain. However, spinal fusion alters the biomechanics of the back, potentially leading to premature disc degeneration at adjacent levels. Artificial discs have been developed as an alternative to cervical or lumbar fusion. This approach is intended to maintain motion and the normal biomechanics of the adjacent vertebrae. Currently, 5 intervertebral devices have FDA PMA approval. The CHARITÉ^® and PRODISC-L^® devices are used for lumbar disc replacement. The PRESTIGE^®, PRODISC-C^® and BRYAN^® devices are used for cervical disc replacement. These devices consist of a sliding plastic or metal core between two metal end plates and are secured in place between the affected vertebrae. The core shifts dynamically within the disc space during spinal motion. The intent of these devices is to restore disc height and physiologic motion as well as preserving adjacent vertebrae.  

Other artificial intervertebral discs have been developed and are currently being investigated in clinical trials.

The Centers for Medicare and Medicaid Services (CMS) issued a national non coverage determination for lumbar artificial disc replacement using any type of lumbar artificial disc for the Medicare population over sixty years of age. For those Medicare beneficiaries younger than sixty years of age, CMS did not issue a national coverage determination, leaving such determinations to be made on a local basis.

Arthroplasty: A surgical procedure in which an artificial joint replaces a damaged joint

Intervertebral discs: Are soft tissues that sit between each vertebra; these discs act as cushions between the vertebrae.

Laminectomy: A surgical procedure for treating spinal stenosis by relieving pressure on the spinal cord; the lamina of the vertebra is removed or trimmed to widen the spinal canal and create more space for the spinal nerves.

Neurogenic: Originating in the nervous system.

Radiculopathy: The irritation of a nerve root at any level of the spine which can be caused by protrusion of a disc.

Vertebrae: Bones that make up the spinal column, which surround and protect the spinal cord.

The following codes for treatments and procedures applicable to this document 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.

When services are Investigational and Not Medically Necessary:

Future ICD-10 coding (effective 10/01/2013)
A draft of ICD-10 Coding related to this document, as it might look today, is available for reference and comments at: Appendix 1: Future ICD-10 coding

Peer Reviewed Publications:

1. Bertagnoli R, Yue JJ, Nanieva R, et al. Lumbar total disc arthroplasty in patients older than 60 years of age: a prospective study of the ProDisc prosthesis with 2-year minimum follow-up period. J Neurosurg Spine. 2006; 4(2):85-90.
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. 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 CHARITÉ^® artificial disc versus lumbar fusion: part I: evaluation of clinical outcomes. Spine. 2005; 30(14):1565-1575.
4. Burkus JK, Haid RW, Traynelis VC, Mummaneni PV. Long-term clinical and radiographic outcomes of cervical disc replacement with the Prestige disc: results from a prospective randomized controlled clinical trial. J Neurosurg Spine. 2010; 13(3):308-318.
5. Chung SS, Lee CS, Kang CS. Lumbar Total Disc Replacement Using ProDisc II: A prospective study with a 2-year minimum follow-up. J Spinal Disord Tech. 2006; 19(6):411-415.
6. Coric D, Finger F, Boltes P. Prospective randomized controlled study of the Bryan Cervical Disc: early clinical results from a single investigational site. J Neurosurg Spine. 2006; 4(1):31-35.
7. Delamarter R,  Murrey D,   Janssen M,  et al. Results at 24 months from the prospective, randomized, multicenter Investigational Device Exemption trial of ProDisc-C versus anterior cervical discectomy and fusion with 4-year follow-up and continued access patients. SAS Journal. 2010; 4(4):122-128.
8. 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):705-15.  
9. Freeman BJ, Davenport J. Total disc replacement in the lumbar spine: a systematic review of the literature. Eur Spine J. 2006; 15 Suppl 3:S439-447.
10. Garrido BJ, Taha TA, Sasso RC: clinical outcomes of Bryan cervical disc arthroplasty: a prospective, randomized, controlled, single site trial with 48-month follow-up. J Spinal Disord Tech 23: 2010.
11. 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. Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves, March 2004.  J Neurosurg Spine, 2004; 1:143-154.
12. 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  CHARITÉ^® artificial disc versus lumbar fusion: five-year follow-up. Spine J. 2009; 9(5):374-386.  
13. Heller JG, Sasso RC, Papadopoulos SM et al. Comparison of BRYAN^® cervical disc arthroplasty with anterior cervical decompression and fusion: clinical and radiographic results of a randomized, controlled, clinical trial. Spine 2009; 34(2):101-107.
14. Leary SP, Regan JJ, Lanman TH, Wagner WH. Revision and explanation strategies involving the CHARITÉ^® lumbar artificial disc replacement. Spine. 2007. 20; 32(9):1001-1011.
15. Leivseth G, Braaten S, Frobin W, Brinckmann P. Mobility of lumbar segments instrumented with ProDisc II prosthesis: a two-year follow-up study. Spine. 2006; 31(15):1726-1733.
16. 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; 15; 30(14):1576-1583.
17. Mummaneni PV, Burkus JK, Haid RW, et al. Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial. J Neurosurg Spine. 2007; 6(3):198-209.
18. Murrey D, Janssen M, Delamarter R. et al. Results of the prospective, randomized, controlled multicenter Food and Drug Administration investigational device exemption study of the PRODISC-C^®  total disc replacement versus anterior discectomy and fusion for the treatment of 1-level symptomatic cervical disc disease. Spine J 2009; 9(4):275-286.
19. Nabhan A, Ahlhelm F, Pitzen T, et al. Disc replacement using PRODISC-C^® versus fusion: a prospective randomized and controlled radiographic and clinical study. Eur Spine J. 2007; 16(3):423-430.
20. Pocock SJ. The pros and cons of noninferiority trials. Fundamental Clin Pharmacol. 2002; (17):483-490.
21. Porchet F, Metcalf NH. Clinical outcomes with the Prestige II cervical disc: preliminary results from a prospective randomized clinical trial. Neurosurg Focus. 2004; 1517(3):E6.
22. Robertson JT, Metcalf NH. Long-term outcome after implantation of the Prestige I disc in an end-stage indication: 4-year results from a pilot study. Neurosurg Focus. 2004; 1517(3):E10.
23. Sasso RC, Smucker JD, Hacker RJ, Heller JG. Artificial disc versus fusion: a prospective, randomized study with 2-year follow-up on 99 patients. Spine. 2007; 32(26):2933-2940;
24. Sasso RC, Smucker JD, Hacker RJ, Heller JG. Clinical outcomes of BRYAN^® cervical disc arthroplasty: a prospective, randomized, controlled, multicenter trial with 24-month follow-up. J Spinal Disord Tech. 2007; 20(7):481-491.
25. 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.
26. Siepe CJ, Mayer HM, Heinz-Leisenheimer M, Korge A. Total lumbar disc replacement: different results for different levels. Spine. 2007; 32(7): 782-790.
27. van den Eerenbeemt KD, Ostelo RW, van Royen BJ, et al. Total disc replacement surgery for symptomatic degenerative lumbar disc disease: a systematic review of the literature. Eur Spine J. 2010; 19(8):1262-1280.
28. 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.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Blue Cross Blue Shield Association. Artificial lumbar disc replacement. TEC Assessment, 2007; 22(02).
2. Blue Cross Blue Shield Association. Artificial vertebral disc replacement. TEC Assessment, 2005; 20(01).
3. Blue Cross Blue Shield Association. Artificial intervertebral disc arthroplasty for treatment of degenerative disc disease of the cervical spine. TEC Assessment, 2008; 22(12).
4. Centers for Medicare and Medicaid Services. National Coverage Determination for Lumbar Artificial Disc Replacement (LADR) NCD #150.10. Effective date July 17, 2007. Available at: http://www.cms.hhs.gov/mcd/index_chapter_list.asp. Accessed on June 21, 2010.
5. National Institute of Neurological Disorders and Stroke (NINDS). Low back pain fact sheet. 2009. Available at:  http://www.ninds.nih.gov/disorders/backpain/detail_backpain.htm#102233102 . Accessed on June 21, 2010.
6. North American Spine Society (NASS). Diagnosis and Treatment of Cervical Radiculopathy from Degenerative Disorders. 2010. Available at: http://www.spine.org/Documents/Cervical_Radiculopathy.pdf  Accesed on July 11, 2011.
7. U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). Post-Approval Studies. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm?sb=dtnd. Accessed on July 12, 2011.
8. U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). New Device Approval BRYAN^® Cervical Disc - P060023. Available at:  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P060023. Accessed on JJuly 12, 2011.
9. U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). New Device Approval CHARITÉ^® Artificial Disc - P040006. Available at:  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P040006 . Accessed on July 12, 2011.
10. U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). New Device Approval PRESTIGE^® Cervical Disc System - P060018. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P060018. Accessed on July 12, 2011.
11. U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). New Device Approval PRODISC^®-C Total Disc Replacement - P070001. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P070001. Accessed on July 12, 2011.
12. U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). New Device Approval PRODISC^®-L Total Disc Replacement - P050010. Available at:  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=7814 . Accessed on July 12, 2011.

AcroFlex®
Artificial Discs
BRYAN^®
CHARITÉ^®
FlexiCore™
Interspinous Implant
Intervertebral Discs
Maverick™
PRESTIGE^®
PRODISC-C^®
PRODISC-L^®

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.