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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.

SUBMITTER: Radcliff K

PROVIDER: S-EPMC5435630 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Bias in cervical total disc replacement trials.

Radcliff Kristen K Siburn Sean S Murphy Hamadi H Woods Barrett B Qureshi Sheeraz S

Current reviews in musculoskeletal medicine 20170601 2

<h4>Purpose of review</h4>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.<h4>Recent findings</h4>Recent studies that compare CDR and ACDF have demonstrated equivalent or superior outco ...[more]

PMID: 28337733

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Project description:BackgroundDespite being considered the standard surgical procedure for symptomatic cervical disc disease, anterior cervical decompression and fusion invariably accelerates adjacent segment degeneration. Cervical total disc replacement is a motion-preserving procedure developed as a substitute to fusion. Whether cervical total disc replacement is superior to fusion remains unclear.MethodsWe comprehensively searched PubMed, EMBASE, Medline, and the Cochrane Library in accordance with the inclusion criteria to identify possible studies. The retrieved results were last updated on December 12, 2014. We classified the studies as short-term and midterm follow-up.ResultsNineteen randomized controlled trials involving 4516 cases were identified. Compared with anterior cervical decompression and fusion, cervical total disc replacement had better functional outcomes (neck disability index [NDI], NDI success, neurological success, neck pain scores reported on a numerical rating scale [NRS], visual analog scales scores and overall success), greater segmental motion at the index level, fewer adverse events and fewer secondary surgical procedures at the index and adjacent levels in short-term follow-up (P < 0.05). With midterm follow-up, the cervical total disc replacement group indicated superiority in the NDI, neurological success, pain assessment (NRS), and secondary surgical procedures at the index level (P < 0.05). The Short Form 36 (SF-36) and segmental motion at the adjacent level in the short-term follow-up showed no significant difference between the two procedures, as did the secondary surgical procedure rates at the adjacent level with midterm follow-up (P > 0.05).ConclusionsCervical total disc replacement presented favorable functional outcomes, fewer adverse events, and fewer secondary surgical procedures. The efficacy and safety of cervical total disc replacement are superior to those of fusion. Longer-term, multicenter studies are required for a better evaluation of the long-term efficacy and safety of the two procedures.

Project description:BackgroundAnterior cervical discectomy and fusion (ACDF) has been widely used in cervical spondylosis, but adjacent segment degeneration/disease (ASD) was inevitable. Cervical total disc replacement (TDR) could reduce the stress of adjacent segments and retard ASD in theory, but the superiority has not been determined yet. This analysis aimed that whether TDR was superior to ACDF for decreasing adjacent segment degeneration (ASDeg) and adjacent segment disease (ASDis).MethodsA meta-analysis was performed according to the guidelines of the Cochrane Collaboration with PubMed, EMBASE, Cochrane Library and CBM (China Biological Medicine) databases. It included randomized controlled trials (RCTs) that reported ASDeg, ASDis, and reoperation on adjacent segments after TDR and ACDF. Two investigators independently selected trials, assessed methodological quality, and evaluated the quality of this meta-analysis using the grades of recommendation, assessment, development, and evaluation (GRADE) approach.ResultsEleven studies with 2632 patients were included in the meta-analysis. The overall rate of ASD in TDR group was lower than ACDF group (OR?=?0.6; 95% CI [0.38, 0.73]; P?<?0.00001). Both the incidence of ASDeg and the reoperation rate were statistically lower in the TDR group than in the ACDF group (OR?=?0.58, P?<?0.00001; OR?=?0.52, P?=?0.01, respectively). Subgroup analysis was performed according to the follow-up time and trial site; the rate of ASDeg was lower in patients underwent TDR no matter the follow-up time, and TDR tended to increase the superiority across time. The rate of ASDeg was also lower with TDR both in the USA and China (P?<?0.0001, P?=?0.03, respectively). But the cost-effectiveness result might be prone to neither of the two surgery approaches. According to GRADE, the overall quality of this meta-analysis was moderate.ConclusionsTDR decreased the rates of ASDeg and reoperation compared with that of ACDF, and the superiority may become more apparent over time. We cautiously and slightly suggest adopting TDR according to the GRADE but may not believe it excessively.

Project description:BackgroundThe purpose of this study is to present clinical outcome data from a 2-year post-market study of a viscoelastic one-piece cervical total disc replacement (TDR) in Europe.MethodsThirty-nine patients were implanted at five surgical sites in an European post-market clinical study. Clinical outcomes included improvement of neck disability index (NDI) and visual analog scale scores for neck and arm pain from baseline to 2-year follow-up, neurological examinations, patients view on the success of surgery, complications, and subsequent surgical interventions.ResultsThirty patients had the Freedom® Cervical Disc (FCD) implanted at a single level, and nine patients were implanted at two adjacent levels. The population had a similar distribution of male [20] and female [19] subjects, with a mean age of 45 years. All self-administered outcome measures showed significant clinically important improvements from baseline to the 2-year follow-up. Mean preoperative NDI score improved from 48% to 20%, 13%, 8%, 6% and 4% at 6 weeks, 3, 6, 12, and 24 months, respectively. Average preoperative visual analog scale (VAS) scores of the neck, right and left arm pain intensity and frequency showed significant improvement. All neurological outcome measurements showed immediate improvement from preoperative values and continued improvement throughout 2 years follow-up. From pre-op to 24 months, neurological deficits declined in the population from 21% to 6% for reflex function, 62% to 17% for sensory function, and 38% to 3% for motor function. No patients experienced a deterioration in any measured outcomes compared with the preoperative situation. Patient satisfaction increased over 2 years post-op, with 83% of patients responding that they would "definitely" choose to have the same treatment for their neck/arm condition and another 11% responding that they would "probably" choose to have the same treatment.ConclusionsThe FCD performs as expected in patients with single-level and two-level degenerative disc disease.

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Bias in cervical total disc replacement trials.

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Bias in cervical total disc replacement trials.

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