Bias in cervical total disc replacement trials
- PMID: 28337733
- PMCID: PMC5435630
- DOI: 10.1007/s12178-017-9399-2
Bias in cervical total disc replacement trials
Abstract
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 medium- and 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. 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.
Keywords: Anterior cervical discectomy fusion; Bias; Cervical disc replacement; Cervical radiculopathy.
Conflict of interest statement
Conflict of interest
Kris Radcliff reports personal fees from Globus Medical, personal fees from DePuy, personal fees from Stryker, personal fees from Medtronic, personal fees from Orthopedic Sciences, Inc., personal fees from NuVasive, personal fees from 4 Web Medical, other from LDR Medical (now Zimmer), outside the submitted work, and shareholder status at Rothman Institute.
Sheeraz Qureshi is a board or committee member for the following organizations: AAOS, Cervical Spine Research Society, Musculoskeletal Transplant Foundation, and NASS. He is on the editorial or governing boards of the following organizations: Clinical Orthopaedics and Related Research, Contemporary Spine Surgery, Global Spine Journal, Spine, and Spine Journal. Dr. Qureshi has also received speaking/consultancy fees from the following organizations: Globus Medical, Medtronic, Medtronic Sofamor Danek, Orthofix, Inc., Stryker, and Zimmer.
All other authors declare no conflict of interest.
Human and animal rights and informed consent
This article does not contain any studies with human or animal subjects performed by any of the authors.
References
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- Gornet MF, McConnell J. R., Burkus J. K. et al. Two-level cervical disc arthroplasty with PRESTIGE LP disc versus ACDF: a prospective, randomized, controlled multicenter clinical trial with 24-month results. Paper presented at: 30th Annual Meeting of the North American Spine Society; October 2015, 2015; Chicago, IL.
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