ISASS Policy Statement – Lumbar Artificial Disc

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ISASS Policy Statement – Lumbar Artificial Disc

 

Jack Zigler, MD

Texas Back Institute, Plano, TX

Rolando Garcia, MD, MPH, FAAOS

Orthopedic Care Center, Aventura, FL

 

This paper was originally published here.

A PDF version of this Policy Statement can be accessed here.

 

Purpose

The primary goal of this Policy Statement is to educate patients, physicians, medical providers, reviewers, adjustors, case managers, insurers, and all others involved or affected by insurance coverage decisions regarding lumbar disc replacement surgery.

Procedures

This Policy Statement was developed by a panel of physicians selected by the Board of Directors of ISASS for their expertise and experience with lumbar TDR. The panel’s recommendation was entirely based on the best evidence-based scientific research available regarding the safety and effectiveness of lumbar TDR.

Background

Most of the major health insurance carriers in the US, including UnitedHealth, Aetna, Humana, and most Blue Cross Blue Shield affiliates, do not provide coverage for single level lumbar TDR even in patients meeting strict selection criteria. As a result, millions of Americans with chronic and debilitating lumbar degenerative disc disease who might reasonably benefit from a lumbar TDR are denied access to this technology based solely on their insurance carriers coverage policy.

The most common explanation for denying coverage for lumbar TDR is that the technology is considered “experimental and investigational.” Some carriers indicate that “the long-term clinical outcome of lumbar disc replacement is unclear. The evidence from uncontrolled long-term studies suggests that potential degeneration of adjacent discs and facets and wear of the polyethylene part of the disc may occur and that, in some cases, revision surgery may be needed.” Statements like this are disingenuous, choosing to ignore the long-term outcomes from well-controlled Level 1 studies demonstrating decreased adjacent segment degeneration, minimal component wear issues, and lower revision rates than fusion.

Rationale

A common definition of an experimental technique is one that is new and untested.

A common definition of an investigational technique is one that is not approved and under investigation in clinical trials.

Evaluation of peer reviewed published literature and publicly-debated scientific presentations provides extensive evidence that lumbar disc replacement is neither experimental nor investigational. It has been extensively tested and has received FDA approval after careful and lengthy evaluation of multicenter Level 1 data. Lumbar TDR is not new. The idea of replacing damaged or degenerated lumbar discs started in the 1950’s.(1,2)

Over the last several decades, multiple attempts have been made to replace painful lumbar disc with implants that maintain motion at the operative level. The Charite artificial disc, developed in Berlin in the 1980s by Drs. Karin Buttner-Janz and Kurt Schellnack was first implanted in the US in 2000 to start a multicenter prospective randomized IDE study. Since 2000, tens of thousands of patients have been treated in the US and worldwide with an increasing inventory of lumbar disc implants. Although some critics speculated that the widespread availability of lumbar TDR would lead to large failure rates and high levels of revision, a detailed and unbiased review of the published literature demonstrates otherwise. Most clinicians and scientists agree that the majority of complications associated with lumbar TDR implantation are related to errors in patient selection, deviating from well established inclusion and exclusion criteria (Table 1Table 2).

Table 1. Inclusion and Exclusion Criteria for ProDisc-L (from the FDA SS&E labelling document).

Inclusion Exclusion
  • Degenerative Disc Disease (DDD) in one vertebral level between L3 and S1. Diagnosis of DDD requires back and/or leg (radicular pain); and radiographic confirmation of any 1 of the following by CT, MRI, discography, plain film, myelography and/or flexion/extension films: 
    • Instability (≥3mm translation or ≥5° angulation;
    • Decreased disc height >2mm;
    • Scarring/thickening of annulus fibrosis;
    • Herniated nucleus pulposus; or
    • Vacuum phenomenon
  • Age between 18 and 60 years
  • Failed at least 6 months of conservative treatment
  • Oswestry Low Back Pain Disability Questionnaire score of at least 20/50 (40%) (Interpreted as moderate/severe disability)
  • Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and
  • Signed inform consent
  • No more than 1 vertebral level may have DDD, and all diseased levels must be treated
  • Patients with involved vertebral endplates dimensionally smaller than 34.5 mm in the medial-lateral and/or 27 mm in the anterior-posterior directions
  • Known allergy to titanium, polyethylene, cobalt, chromium or molybdenum
  • Prior fusion surgery at any vertebral level
  • Clinically compromised vertebral bodies at the affected level due to current or past trauma
  • Radiographic confirmation of facet joint disease or degeneration
  • Lytic spondylolisthesis or spinal stenosis
  • Degenerative spondylolisthesis of grade > 1
  • Back or leg pain of unknown etiology
  • Osteopenia or osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients to determine if a DEXA scan is required. If DEXA is required, exclusion will be defined as a DEXA bone density measured T score < -2.5.
  • Paget’s disease, osteomalacia or anything other metabolic bone disease (excluding osteoporosis which is addressed above)
  • Morbid obesity defined as a body mass index > 40 or a weight more than 100 lbs. over ideal body weight
  • Pregnant or interested in becoming pregnant in the next 3 years
  • Active infection – systemic or local
  • Taking medication or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids)
  • Rheumatoid arthritis or other autoimmune disease
  • Systemic disease including AIDS, HIV, Hepatitis
  • Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer) unless he/she has been treated with curative intent and there has been no clinical signs or symptoms of the malignancy for at least 5 years

Table 2. Indications and Contraindications for ProDisc-L.

Indications Contraindications
The ProDisc-L Total Disc Replacement is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (DDD) at one level from L3-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients should have no more than Grade 1 spondylolisthesis at the involved level. Patients receiving the ProDisc-L Total Disc Replacement should have failed at least six months of conservative treatment prior to implantation of the ProDisc-L Total Disc Replacement. The ProDisc-L Total Disc Replacement should not be implanted in patients with the following conditions:

  • Active systemic infection or infection localized to the site of implantation
  • Osteopenia or osteoporosis defined as DEXA bone density measured T-score < -1.0
  • Bony lumbar spinal stenosis
  • Allergy or sensitivity to implant materials (cobalt, chromium, molybdenum, polyethylene, titanium)
  • Isolated radicular compression syndromes, especially due to disc herniation
  • Pars defect
  • Involved vertebral endplate that is dimensionally smaller than 34.5 mm in the medial-lateral and/or 27mm in the anterior-posterior directions
  • Clinically compromised vertebral bodies at the affected level due to current or past trauma
  • Lytic spondylolisthesis or degenerative spondylolisthesis of grade > 1

In 2005 Blumenthal et al(3), published the result of the first prospective, randomized trial comparing lumbar disc replacement with the Charite to ALIF. The study represented the initial US experience with lumbar disc replacement. 375 patients were enrolled in 14 sites across the US. The authors reported lower levels of pain and disability at all follow up intervals between 6 weeks to 24 months. In addition, the disc replacement group reported higher patient satisfaction, and shorter hospital stay compared to the fusion group. The complication rates in both groups were similar for both groups, but the re-operation rate was significantly lower in the lumbar TDR group compared to the fusion group (5.4% vs. 9.1%).

In 2009, Guyer et al(4), published the 5 year follow up results of the Charite IDE trial. One hundred and thirty-three randomized patients were evaluated at a minimum of 5 years post index operation. The authors reported that the Charite group had a statistically higher success rate than the ALIF group (58% vs 51%; p=0.0359). Although there were no significant differences between the 2 groups in terms of ODI, VAS, or SF-36, patient satisfaction and employment status were higher in the Charite group. The re-operation rate at the index level was 8% for the Charite group and 16% for the fusion group. The authors concluded that although there were no statistically significant differences between the 2 groups in clinical outcomes, the Charite group demonstrated higher patient satisfaction, higher employment status, and lower re-operation rates, while maintaining motion at the operative level.

Longer term follow-ups at 10 years have been reported in Europe, demonstrating durability of lumbar arthroplasty. Lemaire et al(5) reported on 100 Charite patients with minimum 10 year follow-up. Clinically, 62% had an excellent outcome, 28% had a good outcome, and only 10% had a poor outcome. Of the 95 patients eligible to return to work, 91.5% did so. These outcomes compare favorably with results described in the literature for fusion for lumbar DDD.

David et al(6) reported on 106 Charite patients with mean follow-up of 13.2 years. Clinical outcomes and the rate of return to work were excellent overall. The rate of adjacent level disease requiring operation (2.8%) compared very favorably with rates of up to 30% in patients treated with fusion.

In a more recent publication, Zigler et al(7) reported the results of the 5 year follow up of the ProDisc-L study. Of the 236 original cohort of patients, 82% were available for follow up at a minimum of 5 years post-op. Although both groups demonstrated significant improvements in ODI compared to pre op values, the percentage of patients indicating they would have the surgery again was higher in the ProDisc-L group compared to the fusion group (82% vs. 68%). In addition, the re-operation at the index level was lower for the ProDisc group versus the fusion group (8% vs. 12%). The authors concluded that although fusion and disc replacement are reasonable alternatives for well selected patients, patients undergoing lumbar disc replacement have higher patient satisfaction and avoid the segmental stiffness associated with fusion.

As a companion article Zigler et al(8) also reported on radiographic adjacent level degeneration as measured by independent radiologic analysis. Comparison of adjacent levels preoperatively and 5 years after surgery demonstrated a threefold increase in adjacent level degeneration in patients who randomized to single level 360 fusion over those who randomized to a ProDisc-L implant. Reoperation rates at the adjacent level were twice as high in the post-fusion patients at 5 years.

Although only ProDisc-L is currently FDA approved in the US for commercial use in the lumbar spine, there are several prospective studies published on the clinical and radiographic outcomes of other lumbar arthroplasty implants in the FDA pipeline. Several lumbar implants are used outside the US (OUS) with thousands of patients implanted, but have not yet gone through an IDE approval for sale in the US.

Gornet et al(9) published results of the IDE trial using the Maverick metal on metal implant. The study was the largest prospective, randomized trial comparing lumbar TDR to ALIF with a metal cage and BMP. 577 patients were included in this study, including 405 in the TDR group and 172 in the ALIF group. The disc replacement group reported statistically superior outcomes (p<0.05) at all post-operative evaluations in ODI, back pain, and SF-36. Operative times and blood loss were higher in the Maverick group, whereas device related adverse events were lower in the Maverick group. The authors concluded that they had demonstrated statistical superiority of the Maverick arthroplasty versus fusion on key clinical outcomes including improved physical function, reduced pain, and earlier return to work. Maverick is implanted only OUS. Metal on metal arthroplasty devices are under intense scrutiny by the FDA as well as by the surgeon community. New MOM designs are likely to face an even more strenuous regulatory path in the future.

Sasso et al(10) published their results on a metal on metal implant. The study included prospective data from 2 sites in a multicenter trial comparing lumbar TDR with the FlexiCore implant versus circumferential fusion. 67 patients were included in this prospective randomized trial. Operative time, blood loss, and hospital stay were statistically significantly lower in the FlexiCore group. The authors concluded that the FlexiCore compared very favorably to circumferential fusion for the treatment of lumbar DDD unresponsive to conservative treatment. This implant did not complete the FDA approval process.

In addition to US studies regarding patients enrolled in IDE trials, there are several published European studies comparing lumbar TDR to fusion. Skold et al(11) reported results of a prospective randomized studies comparing lumbar TDR to fusion. Of the 152 patients included in this study, 80 were randomized to TDR while 72 were assigned to the fusion group. 99% of the patients were available for follow up at 5 years post-op. At follow up the percentage of patients who were totally pain-free was significantly higher in the TDR group versus the fusion group (38% vs 15%; p<0.003). The authors also reported better improvement in VAS and ODI in the lumbar TDR group, with no difference in complications or reoperations.

Although not a randomized study, Siepe et al(12) reported their prospective outcomes 5 to 10 years after lumbar TDR with the ProDisc-L implant. The authors reported on 181 patients at an average follow up of 7.4 years. The authors reported significant improvements in VAS and ODI at all postoperative follow up stages (p<0.0001), and concluded that their results demonstrated satisfactory and maintained mid- to long-term clinical results after a mean follow-up of 7.4 years. The authors stated that the fears of excessive late complications or reoperations following TDR procedures cannot be substantiated with the present data.

Conclusion

Science in general, and particularly clinical medicine, has evolved from anecdotal and retrospective investigations to more objective, rigorous, and prospective scientific investigation. In the face of strong Level I prospective randomized multicenter studies with long-term follow-up, it is inexcusable that treatment guidelines be directed by personal opinions and business-based decisions. Treatment guidelines should be based on these tested and proven therapeutic algorithms.

Our interpretation and understanding of the efficacy and safety of clinical interventions can only be dictated by well-established evidenced based guidelines.

Scientifically proven techniques and technologies must be accepted for the benefit of appropriate patients. One of the best values of these multiple IDE studies has been to identify the patients who would predictably benefit from lumbar arthroplasty. IDE study inclusion and exclusion criteria should provide an easy avenue for insurance payors to define the patients they can approve for lumbar disc replacement, since the outcomes for these patients should be predictable.

Based on a thorough review of the best available evidence-based scientific literature the International Society for the Advancement of Spine Surgery concludes that lumbar TDR is not new, experimental, or investigational. It is a well-tested technology which should predictably lead to better outcomes and less complications than fusion surgery, as well as a protective effect on adjacent levels.

There is sufficient evidence-based scientific evidence to support the safety and efficacy of single level lumbar TDR for patients meeting well established selection criteria. ISASS would support patient authorization guidelines that mirror the selection criteria from the IDE studies, as long as the device is implanted by a trained experienced spine surgeon.

There are now several long-term prospective and retrospective studies available on lumbar TDR which provide objective evidence regarding their safety and effectiveness. Data from prospective randomized clinical trials have reported consistently low rates of re-operations, and extremely low levels of particulate wear debris complications. A list of relevant research is available below.

Based on sound analysis of the scientific literature, the International Society for the Advancement of Spine Surgery recommends universal coverage for single level lumbar TDR in patients meeting the established selection criteria.

References

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  2. Fernstrom U. Arthroplasty with intercorporal endoprothesis in herniated disc and in painful disc. Acta Chir Scand Suppl 1966;357:154-9.
  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 CHARITE artificial disc versus lumbar fusion: Part i: Evaluation of clinical outcomes. Spine 2005;30:1565-75.
  4. 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;9:374-86.
  5. Lemaire JP, Carrier H, Sariali el H, et al. Clinical and radiological outcomes with the Charite artificial disc: A 10-year minimum follow-up. J Spinal Disord Tech 2005;18:353-9.
  6. David T. Long-term results of one-level lumbar arthroplasty: Minimum 10-year follow-up of the CHARITE artificial disc in 106 patients. Spine 2007;32:661-6.
  7. Zigler JE, Delamarter RB. Five-year results of the prospective, randomized, multicenter, Food and Drug Administration investigational device exemption study of the ProDisc-l total disc replacement versus circumferential arthrodesis for the treatment of single-level degenerative disc disease. J Neurosurg Spine 2012;17:493-501.
  8. Zigler JE, Glenn J, Delamarter RB. Five-year adjacent-level degenerative changes in patients with single-level disease treated using lumbar total disc replacement with ProDisc-l versus circumferential fusion. J Neurosurg Spine 2012;17:504-11.
  9. Gornet MF, Burkus JK, Dryer RF, et al. Lumbar disc arthroplasty with maverick disc versus stand-alone interbody fusion: A prospective, randomized, controlled, multicenter Investigational Device Exemption trial. Spine 2011;36:E1600-E11.
  10. Sasso RC, Foulk DM, Hahn M. Prospective, randomized trial of metal-on-metal artificial lumbar disc replacement: Initial results for treatment of discogenic pain. Spine 2008;33:123-31.
  11. 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;22:2288–95.
  12. 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;14:1417-31.

Additional Literature on Lumbar Total Disc Replacement

Aghayev E, Etter C, Barlocher C, et al. Five-year results of lumbar disc prostheses in the SwissSpine registry. Eur Spine J 2014;23:2114-26.

Aghayev E, Henning J, Munting E, et al. Comparative effectiveness research across two spine registries. Eur Spine J 2012;21:1640-7.

Aghayev E, Roder C, Zweig T, et al. Benchmarking in the SwissSpine registry: Results of 52 Dynardi lumbar total disc replacements compared with the data pool of 431 other lumbar disc prostheses. Eur Spine J 2010;19:2190-9.

Alahmadi H, Deutsch H. Outcome of salvage lumbar fusion after lumbar arthroplasty. Asian Spine J 2014;8:13-8.

Auerbach JD, Ballester CM, Hammond F, et al. The effect of implant size and device keel on vertebral compression properties in lumbar total disc replacement. Spine J 2010;10:333-40.

Auerbach JD, Jones KJ, Milby AH, et al. Segmental contribution toward total lumbar range of motion in disc replacement and fusions: A comparison of operative and adjacent levels. Spine 2009;34:2510-7.

Auerbach JD, Wills BP, McIntosh TC, et al. Evaluation of spinal kinematics following lumbar total disc replacement and circumferential fusion using in vivo fluoroscopy. Spine 2007;32:527-36.

Aunoble S, Donkersloot P, Le Huec JC. Dislocations with intervertebral disc prosthesis: Two case reports. Eur Spine J 2004;13:464-7.

Aunoble S, Meyrat R, Al Sawad Y, et al. Hybrid construct for two levels disc disease in lumbar spine. Eur Spine J 2010;19:290-6.

Austen S, Punt IM, Cleutjens JP, et al. Clinical, radiological, histological and retrieval findings of Activ-L and Mobidisc total disc replacements: A study of two patients. Eur Spine J 2012;21:513-20.

Awe OO, Maltenfort MG, Prasad S, et al. Impact of total disc arthroplasty on the surgical management of lumbar degenerative disc disease: Analysis of the nationwide inpatient sample from 2000 to 2008. Surg Neurol Int 2011;2:139.

Balderston JR, Gertz ZM, McIntosh T, et al. Long-term outcomes of 2-level total disc replacement using ProDisc-L: Nine- to 10-year follow-up. Spine 2014;39:906-10.

Bassani C. Early and late complication in Charité TDR: An anterior revision surgery after 7 years. Argo Spine 2009;21:159-61.

Baxter RM, Macdonald DW, Kurtz SM, et al. Severe impingement of lumbar disc replacements increases the functional biological activity of polyethylene wear debris. J Bone Joint Surg Am 2013;95:e751-9.

Berg S, Tropp H. Results from a randomized controlled study between total disc replacement and fusion compared with results from a spine register. SAS J 2010;4:68–74.

Berg S, Tullberg T, Branth B, et al. Total disc replacement compared to lumbar fusion: A randomised controlled trial with 2-year follow-up. Eur Spine J 2009;18:1512-9.

Berry MR, Peterson BG, Alander DH. A granulomatous mass surrounding a Maverick total disc replacement causing iliac vein occlusion and spinal stenosis: A case report. J Bone Joint Surg Am 2010;92:1242-5.

Bertagnoli R, Kumar S. Indications for full prosthetic disc arthroplasty: A correlation of clinical outcome against a variety of indications. Eur Spine J 2002;11 Suppl 2:S131-6.

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;4:91-7.

Bertagnoli R, Yue JJ, Kershaw T, et al. Lumbar total disc arthroplasty utilizing the ProDisc prosthesis in smokers versus nonsmokers: A prospective study with 2-year minimum follow-up. Spine 2006;31:992-7.

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;4:85-90.

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;30:2230-6.

Bertagnoli R, Yue JJ, Shah RV, et al. The treatment of disabling multilevel lumbar discogenic low back pain with total disc arthroplasty utilizing the ProDisc prosthesis: A prospective study with 2-year minimum follow-up. Spine 2005;30:2192-9.

Bisseling P, Zeilstra DJ, Hol AM, et al. Metal ion levels in patients with a lumbar metal-on-metal total disc replacement: Should we be concerned? J Bone Joint Surg Br 2011;93:949-54.

Blondel B, Tropiano P, Gaudart J, et al. Clinical results of lumbar total disc arthroplasty in accordance with Modic signs, with a 2-year-minimum follow-up. Spine 2011;36:2309-15.

Blondel B, Tropiano P, Gaudart J, et al. Clinical results of total lumbar disc replacement regarding to various aetiologies of the disc degeneration: A study with a 2 years minimal follow-up. Spine 2011;36:E313-E9.

Blumenthal S, Guyer R, Geisler F, et al. The first 18 months following Food and Drug Administration approval of lumbar total disc replacement in the United States: Reported adverse events outside an Investigational Device Exemption study environment. SAS J 2007;1:8-11.

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 2005;30:1565-75.

Blumenthal SL, Zigler JE, Guyer RD, et al. Long-term evaluation of re-operation rates for lumbar total disc replacement and fusion: Analysis of 1,237 patients. International Society for the Study of the Lumbar Spine. Scottsdale, Arizona, 2013.

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Buttacavoli FA, Delamarter RB, Kanim LEA. Cost comparison of patients with 3-level artificial total lumbar disc replacements versus 360° fusion at 3 contiguous lumbar vertebral levels: An analysis of compassionate use at 1 site of the us investigational device exemption clinical trial. SAS J 2010; 4:107-14.

Buttner-Janz K, Guyer RD, Ohnmeiss DD. Indications for lumbar total disc replacement: Selecting the right patient with the right indication for the right total disc Internat J Spine Surg 2015;8:10.14444/1012.

Buttner-Janz K, Schellnack K, Zippel H. Biomechanics of the SB Charite lumbar intervertebral disc endoprosthesis. Int Orthop 1989;13:173-6.

Buttner-Janz K. Optimal minimally traumatic approach for the SB Charite artificial disc. Eur Spine J 2002;11 Suppl 2:S111-4.

Cabraja M, Schmeding M, Koch A, et al. Delayed formation of a devastating granulomatous process after metal-to-metal lumbar disc arthroplasty. Spine 2012;37:E809–E13.

Cakir B, Schmidt R, Mattes T, et al. Index level mobility after total lumbar disc replacement: Is it beneficial or detrimental? Spine 2009;34:917-23.

Canadian Agency for Drugs and Technologies in Health. Compressible non-articulating disc prostheses: A review of clinical and cost-effectiveness, safety and guidelines. 2014.

Chen SH, Zhong ZC, Chen CS, et al. Biomechanical comparison between lumbar disc arthroplasty and fusion. Med Eng Phys 2009;31:244-53.

Chen WC, Liu YL, Lin KJ, et al. Concave polyethylene component improves biomechanical performance in lumbar total disc replacement–modified compressive-shearing test by finite element analysis. Med Eng Phys 2012;34:498-505.

Chen WM, Park C, Lee K, et al. In situ contact analysis of the prosthesis components of ProDisc-L in lumbar spine following total disc replacement. Spine 2009;34:E716-23.

Choma TJ, Miranda J, Siskey R, et al. Retrieval analysis of a ProDisc-L total disc replacement. J Spinal Disord Tech 2009;22:290-6.

Chung SK, Kim YE, Wang KC. Biomechanical effect of constraint in lumbar total disc replacement: A study with finite element analysis. Spine 2009;34:1281-6.

Chung SS, Lee CS, Kang CS, et al. The effect of lumbar total disc replacement on the spinopelvic alignment and range of motion of the lumbar spine. J Spinal Disord Tech 2006;19:307-11.

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;19:411-5.

Cinotti G, David T, Postacchini F. Results of disc prosthesis after a minimum follow-up period of 2 years. Spine 1996;21:995-1000.

Crawford NR. Biomechanics of lumbar arthroplasty. Neurosurg Clin N Am 2005;16:595-602.

Cunningham BW, Dmitriev AE, Hu N, et al. General principles of total disc replacement arthroplasty: Seventeen cases in a nonhuman primate model. Spine 2003;28:S118-24.

Cunningham BW, Gordon JD, Dmitriev AE, et al. Biomechanical evaluation of total disc replacement arthroplasty: An in vitro human cadaveric model. Spine 2003;28:S110-7.

Cunningham BW, Hu N, Zorn CM, et al. Bioactive titanium calcium phosphate coating for disc arthroplasty: Analysis of 58 vertebral end plates after 6- to 12-month implantation. Spine J 2009;9:836-45.

Cunningham BW, McAfee PC, Geisler FH, et al. Distribution of in vivo and in vitro range of motion following 1-level arthroplasty with the CHARITE artificial disc compared with fusion. J Neurosurg Spine 2008;8:7-12.

Cunningham BW. Basic scientific considerations in total disc arthroplasty. Spine J 2004;4:219S-30S.

Daftari TK, Chinthakunta SR, Ingalhalikar A, et al. Kinematics of a selectively constrained radiolucent anterior lumbar disc: Comparisons to hybrid and circumferential fusion. Clin Biomech (Bristol, Avon) 2012;27:759-65.

Daniels AH, Paller DJ, Koruprolu S, et al. Dynamic biomechanical examination of the lumbar spine with implanted total disc replacement using a pendulum testing system. Spine 2012;37:E1438-43.

David T. Long-term results of one-level lumbar arthroplasty: Minimum 10-year follow-up of the CHARITE artificial disc in 106 patients. Spine 2007;32:661-6.

David T. Lumbar disc prosthesis. Surgical technique, indications and clinical results in 22 patients with a minimum of 12 months follow-up. Eur Spine J 1993;1:254-9.

David T. Revision of a Charite artificial disc 9.5 years in vivo to a new Charite artificial disc: Case report and explant analysis. Eur Spine J 2005;14:507-11.

de Maat GH, Punt IM, van Rhijn LW, et al. Removal of the Charite lumbar artificial disc prosthesis: Surgical technique. J Spinal Disord Tech 2009;22:334-9.

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;93:1-11.

Delécrin J, Allain J, Beaurain J, et al. Does core mobility of lumbar total disc arthroplasty influence sagittal and frontal intervertebral displacement? Radiologic comparison with fixed-core prosthesis. SAS J 2009;3:91–9.

Delecrin J, Allain J, Beaurain J, et al. Effects of lumbar artificial disc design on intervertebral mobility: In vivo comparison between mobile-core and fixed-core. Eur Spine J 2012;21:630-40.

Demetropoulos CK, Sengupta DK, Knaub MA, et al. Biomechanical evaluation of the kinematics of the cadaver lumbar spine following disc replacement with the ProDisc-L prosthesis. Spine 2010;35:26-31.

Denoziere G, Ku DN. Biomechanical comparison between fusion of two vertebrae and implantation of an artificial intervertebral disc. J Biomech 2006;39:766-75.

Devin CJ, Myers TG, Kang JD. Chronic failure of a lumbar total disc replacement with osteolysis. Report of a case with nineteen-year follow-up. J Bone Joint Surg Am 2008;90:2230-4.

Di Silvestre M, Bakaloudis G, Lolli F, et al. Two-level total lumbar disc replacement. Eur Spine J 2009;18 Suppl 1:64-70.

Dmitriev AE, Gill NW, Kuklo TR, et al. Effect of multilevel lumbar disc arthroplasty on the operative- and adjacent-level kinematics and intradiscal pressures: An in vitro human cadaveric assessment. Spine J 2008;8:918-25.

Dooris AP, Goel VK, Grosland NM, et al. Load-sharing between anterior and posterior elements in a lumbar motion segment implanted with an artificial disc. Spine 2001;26:E122-9.

Eijkelkamp MF, Hayen J, Veldhuizen AG, et al. Improving the fixation of an artificial intervertebral disc. Int J Artif Organs 2002;25:327-33.

Eijkelkamp MF, van Donkelaar CC, Veldhuizen AG, et al. Requirements for an artificial intervertebral disc. Int J Artif Organs 2001;24:311-21.

Erkan S, Rivera Y, Wu C, et al. Biomechanical comparison of a two-level Maverick disc replacement with a hybrid one-level disc replacement and one-level anterior lumbar interbody fusion. Spine J 2009;9:830-5.

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Disclosures

Jack Zigler receives consulting fees from DePuy Synthes. Rolando Garcia receives royalties and consulting fees from Aesculap.

Corresponding Author

Dr. Jack Zigler, Texas Back Institute, 6020 W. Parker Road, Suite 200, Plano TX 75093. jzigler@texasback.com

Originally published 12 March 2015.