Cervical artificial disc replacement versus fusion in the cervical spine: a systematic review comparing multilevel versus single-level surgery

Kepler, Christopher K.; Brodt, Erika D.; Dettori, Joseph R; Albert, Todd J.

doi:10.1055/s-0031-1298605

Cited by 18 publications

(17 citation statements)

References 8 publications

(23 reference statements)

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C erviCal total disc replacement (cTDR) in properly indicated patients with single-level cervical disc pathology has been demonstrated to achieve satisfactory neural decompression and clinical outcomes equivalent to or better 4,6,7,[14][15][16][17][18][19][20][21][22][23][24][25][26][27][28]38 than anterior cervical discectomy and fusion (ACDF) in 7 different prospective, randomized, controlled US FDA trials. Single-level longterm data have been published on the Bryan disc, 34 ProDisc-C, 41 and Prestige ST disc, 8 but this is the first report on the 5-year investigational device exemption (IDE) data for 2-level cervical arthroplasty.

Although both ACDF and cTDR satisfactorily treat clinically symptomatic cervical pathology, arthrodesis alters cervical mechanics 1,2,11 by placing increased stresses on ad- obJective The purpose of this study was to report the outcome of a study of 2-level cervical total disc replacement (Mobi-C) versus anterior cervical discectomy and fusion (ACDF).

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mentioning

confidence: 99%

Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial

Radcliff

Coric

Albert

2016

SPI

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OBJECTIVE The purpose of this study was to report the outcome of a study of 2-level cervical total disc replacement (Mobi-C) versus anterior cervical discectomy and fusion (ACDF). Although the long-term outcome of single-level disc replacement has been extensively described, there have not been previous reports of the 5-year outcome of 2-level cervical disc replacement. METHODS This study reports the 5-year results of a prospective, randomized US FDA investigational device exemption (IDE) study conducted at 24 centers in patients with 2-level, contiguous, cervical spondylosis. Clinical outcomes at up to 60 months were evaluated, including validated outcome measures, incidence of reoperation, and adverse events. The complete study data and methodology were critically reviewed by 3 independent surgeon authors without affiliation with the IDE study or financial or institutional bias toward the study sponsor. RESULTS A total of 225 patients received the Mobi-C cervical total disc replacement device and 105 patients received ACDF. The Mobi-C and ACDF follow-up rates were 90.7% and 86.7%, respectively (p = 0.39), at 60 months. There was significant improvement in all outcome scores relative to baseline at all time points. The Mobi-C patients had significantly more improvement than ACDF patients in terms of Neck Disability Index score, SF-12 Physical Component Summary, and overall satisfaction with treatment at 60 months. The reoperation rate was significantly lower with Mobi-C (4%) versus ACDF (16%). There were no significant differences in the adverse event rate between groups. CONCLUSIONS Both cervical total disc replacement and ACDF significantly improved general and disease-specific measures compared with baseline. However, there was significantly greater improvement in general and disease-specific outcome measures and a lower rate of reoperation in the 2-level disc replacement patients versus ACDF control patients. Clinical trial registration no. NCT00389597 (clinicaltrials.gov)

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confidence: 99%

Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial

Radcliff

Coric

Albert

2016

SPI

Self Cite

123

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“…Despite a plethora of systematic reviews on cervical disc replacement, only a few studies assess publication bias directly [20][21][22][23][24][25][26][27][28][29][30][31]. There are several studies that have demonstrated a publication bias in the cervical disc replacement literature [32,33].…”

Section: Publication Biasmentioning

confidence: 99%

Bias in cervical total disc replacement trials

Radcliff

Siburn

Murphy

et al. 2017

Curr Rev Musculoskelet Med

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Purpose of review Cervical disc replacement (CDR) has emerged as a motion-preserving alternative to anterior cervical discectomy and fusion in selected cases. Despite favorable literature, CDR is not universally accepted because of concerns regarding bias in the existing literature. The purpose of this review is to identify the possible biases in the disc replacement literature. Recent findings Recent studies that compare CDR and ACDF have demonstrated equivalent or superior outcomes, lower rates of secondary surgery, and equivalent safety at mediumand long-term follow-up. In our review, we identified four types of bias that may affect the CDR literature: publication bias, external validity, confounding bias, and financial conflicts of interest. Summary Bias, whether intentional or unintentional, can impact the interpretation and outcome of CDR studies. Recognition of this issue is critical when utilizing the existing literature to determine the efficacy of CDR and designing future studies.

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“…These studies are prospective multicenter trials, in which patients were randomized to undergo arthroplasty or fusion surgery, and success is defined as a composite score based on validated clinical scales. Previous reviews have thoroughly documented these trials and related studies (14)(15)(16) .…”

Section: Clinical Trialsmentioning

confidence: 99%

“…Subsequent studies have demonstrated equivalent or superior clinical outcomes when comparing single level to multilevel CA (46)(47)(48) . In comparison to ACDF, there is evidence to suggest that CA demonstrates improved clinical outcomes; although there are few studies available that evaluate this issue (16,23,49) . The Mobi-C Cervical Disc is currently the only FDA-approved device for one or twolevel disc replacement, and has been demonstrated to maintain effectiveness at 2 and 4 years following implantation (23,50) .…”

Section: Multi-level Diseasementioning

confidence: 99%

Cervical Disc Arthroplasty: An Overview of Past, Present and Future

Staudt¹,

Duggal²

2015

sscd

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Purpose of review: The present article reviews the most recent research into the rationale, patient selection, clinical results and complication profile of cervical arthroplasty. Recent findings: Recent results of prospective randomized control trials comparing cervical disc replacement and anterior fusion have demonstrated safety as well as equal or superior clinical results. In vivo kinematic studies have suggested decreased rates of adjacent segment disease following disc replacement. Increasingly, more studies are examining the complication profile and emerging contra-indications for cervical disc replacement. Summary: Cervical arthroplasty is a promising technique in that is undergoing rapid refinement and development. Further long-term data is eagerly awaited before the role in prevention of adjacent segment disease can be proven.

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Cervical artificial disc replacement versus fusion in the cervical spine: a systematic review comparing multilevel versus single-level surgery

Cited by 18 publications

References 8 publications

Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial

Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial

Bias in cervical total disc replacement trials

Cervical Disc Arthroplasty: An Overview of Past, Present and Future

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