A prospective, randomised, controlled multicentre study comparing cervical disc replacement with anterior cervical decompression and fusion

Zhang, Haoxuan; Shao, Yuandong; Chen, Yu; Hou, Yong; Cheng, Lei; Si, Meng; Lin, Na

doi:10.1007/s00264-014-2497-5

Cited by 53 publications

(37 citation statements)

References 22 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Compared with anterior cervical discectomy and fusion, the cervical disc arthroplasty offers the theoretical biomechanical advantage of preservation of motion at the index level, which reduces stresses at the adjacent levels [12,13]. The equivalency or superiority of the cervical disc arthroplasty as an alternative to anterior cervical discectomy and fusion has been seen in FDA Investigational Device Exemption and other studies [5,7,8,10,22,30,32,34,35,37,38,[42][43][44]. However, there is controversy regarding whether the cervical disc arthroplasty results in a lower frequency of reoperation compared with the anterior cervical discectomy and fusion.…”

Section: Discussionmentioning

confidence: 99%

“…Supplemental material is available with the online version of CORR 1 .). Finally, 12 eligible RCTs were included in our systematic review and meta-analysis [5,8,10,22,30,34,35,37,38,[42][43][44]. The study selection is shown in the PRISMA flowchart (Fig.…”

Section: Study Selectionmentioning

confidence: 99%

“…All 12 studies included in this meta-analysis were parallelgroup randomized trials, eight were conducted in the United States [5,8,10,22,30,35,38,44], and the other four were done in Asia and Europe [34,37,42,43] ( Table 1). The years of publication ranged from 2011 to 2015, and the lengths of followup ranged from 2 to 7 years.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Ten studies reported the secondary surgical procedures at the index level and 11 reported the secondary surgical procedures at the adjacent level. Most of the included studies were multicenter trials [5,8,10,22,30,35,37,38,[42][43][44]; only one was a single-center trial [34], and nine of these studies were industrysponsored [5,8,10,22,30,35,37,38,44].…”

Section: Study Characteristicsmentioning

confidence: 99%

See 3 more Smart Citations

Reoperation After Cervical Disc Arthroplasty Versus Anterior Cervical Discectomy and Fusion: A Meta-analysis

Zhong

Zhu

Zhuang

et al. 2016

Clinical Orthopaedics &Amp; Related Research

View full text Add to dashboard Cite

Background Anterior cervical discectomy and fusion is a standard surgical treatment for cervical radiculopathy and myelopathy, but reoperations sometimes are performed to treat complications of fusion such as pseudarthrosis and adjacent-segment degeneration. A cervical disc arthroplasty is designed to preserve motion and avoid the shortcomings of fusion. Available evidence suggests that a cervical disc arthroplasty can provide pain relief and functional improvements similar or superior to an anterior cervical discectomy and fusion. However, there is controversy regarding whether a cervical disc arthroplasty can reduce the frequency of reoperations. Questions/purposes We performed a meta-analysis of randomized controlled trials (RCTs) to compare cervical disc arthroplasty with anterior cervical discectomy and fusion regarding (1) the overall frequency of reoperation at the index and adjacent levels; (2) the frequency of reoperation at the index level; and (3) the frequency of reoperation at the adjacent levels. Methods PubMed, EMBASE, and the Cochrane Register of Controlled Trials databases were searched to identify RCTs comparing cervical disc arthroplasty with anterior cervical discectomy and fusion and reporting the frequency of reoperation. We also manually searched the reference lists of articles and reviews for possible relevant studies. Twelve RCTs with a total of 3234 randomized patients were included. Eight types of disc prostheses were used in the included studies. In the anterior cervical discectomy and fusion group, autograft was used in one study and allograft in 11 studies. Nine of 12 studies were industry sponsored. Pooled risk ratio (RR) and associated 95% CI were calculated for the frequency of reoperation using random-effects or fixed-effects models depending on the heterogeneity of the included studies. A funnel plot suggested the possible presence of publication bias in the available pool of studies; that is, the shape of the plot suggests that smaller negative or nodifference studies may have been performed but have not been published, and so were not identified and included in this meta-analysis. Results The overall frequency of reoperation at the index and adjacent levels was lower in the cervical disc arthroplasty group (6%; 108/1762) than in the anterior cervical discectomy and fusion group (12%; 171/1472) (RR, 0.54; 95% CI, 0.36-0.80; p = 0.002). Subgroup analyses were performed according to secondary surgical level. Compared with anterior cervical discectomy and fusion, cervical disc arthroplasty was associated with fewer reoperations at the index level (RR, 0.50; 95% CI, 0.37-

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Study Selectionmentioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

See 2 more Smart Citations

Reoperation After Cervical Disc Arthroplasty Versus Anterior Cervical Discectomy and Fusion: A Meta-analysis

Zhong

Zhu

Zhuang

et al. 2016

Clinical Orthopaedics &Amp; Related Research

View full text Add to dashboard Cite

show abstract

“…All eight studies were rated as “low risk of bias” according to the Cochrane Back Review Group criteria. One study [ 59 ] failed to clearly report adequate randomization and only one study provided the information of allocation concealment [ 59 ]. Blinding of patients, surgeons, and assessors were not considered achieved because of the nature of the studies and evident difference of implant design.…”

Section: Resultsmentioning

confidence: 99%

Mid- to Long-Term Outcomes of Cervical Disc Arthroplasty versus Anterior Cervical Discectomy and Fusion for Treatment of Symptomatic Cervical Disc Disease: A Systematic Review and Meta-Analysis of Eight Prospective Randomized Controlled Trials

Ren

Johansen

2016

PLoS ONE

View full text Add to dashboard Cite

PurposeThis study aimed to investigate the mid- to long-term outcomes of cervical disc arthroplasty (CDA) versus anterior cervical discectomy and fusion (ACDF) for the treatment of 1-level or 2-level symptomatic cervical disc disease.MethodsMedline, Embase, and the Cochrane Central Register of Controlled Trials databases were searched to identify relevant randomized controlled trials that reported mid- to long-term outcomes (at least 48 months) of CDA versus ACDF. All data were analyzed by Review Manager 5.3 software. The relative risk (RR) and 95% confidence intervals (CIs) were calculated for dichotomous variables. The weighted mean difference (WMD) and 95%CIs were calculated for continuous variables. A random effect model was used for heterogeneous data; otherwise, a fixed effect model was used.ResultsEight prospective randomized controlled trials (RCTs) were retrieved in this meta-analysis, including 1317 and 1051 patients in CDA and ACDF groups, respectively. Patients after an ACDF had a significantly lower rate of follow-up than that after CDA. Pooled analysis showed patients in CDA group achieved significantly higher rates of overall success, Neck Disability Index (NDI) success, neurological success and significantly lower rates of implant/surgery-related serious adverse events and secondary procedure compared with that in ACDF group. The long-term functional outcomes (NDI, Visual Analog Scale (VAS) neck and arm pain scores, the Short Form 36 Health Survey physical component score (SF-36 PCS)), patient satisfaction and recommendation, and the incidence of superior adjacent segment degeneration also favored patients in CDA group with statistical difference. Regarding inferior adjacent segment degeneration, patients in CDA group had a lower rate without statistical significance.ConclusionsThis meta-analysis showed that cervical disc arthroplasty was superior over anterior discectomy and fusion for the treatment of symptomatic cervical disc disease in terms of overall success, NDI success, neurological success, implant/surgery-related serious adverse events, secondary procedure, functional outcomes, patient satisfaction and recommendation, and superior adjacent segment degeneration.

show abstract

The Fragility of Statistical Findings in Cervical Disc Arthroplasty: a Systematic Review of Randomized Controlled Trials

Megafu,

Nguyen

et al. 2024

Arch Orthop Trauma Surg

View full text Add to dashboard Cite

Purpose This study employs both the fragility index (FI) and fragility quotient (FQ) to assess the level of robustness in the cervical disc arthroplasty (CDA) literature. We hypothesize that dichotomous outcomes involving CDA would exhibit statistical vulnerability. Methods A PubMed search was conducted to evaluate dichotomous data for randomized controlled trials (RCTs) in CDA literature from 2000 to 2023. The FI of each outcome was calculated through the reversal of a single outcome event until significance was reversed. The FQ was calculated by dividing each fragility index by the study sample size. The interquartile range (IQR) was also calculated for the FI and FQ. Results Of the 1561 articles screened, 111 met the search criteria, with 35 RCTs evaluating CDA included for analysis. Six hundred and ninety-three outcome events with 130 significant (P < 0.05) outcomes and 563 nonsignificant (P ≥ 0.05) outcomes were identified. The overall FI and FQ for all 693 outcomes were 5 (IQR 3–7) and 0.019 (IQR 0.011–0.043). Fragility analysis of statistically significant outcomes and nonsignificant outcomes both revealed an FI of 5. All of the studies reported loss to follow-up (LTF) data where 65.7% (23) did not report or reported an LTF greater or equal to 5. Conclusions The literature regarding CDA RCTs lacks statistical robustness and may misrepresent the conclusions with the sole use of the P value. By implementing the FI and FQ along with the P value, we believe the interpretation and contextualization of the clinical data surrounding CDA will be better understood.

show abstract

A prospective, randomised, controlled multicentre study comparing cervical disc replacement with anterior cervical decompression and fusion

Cited by 53 publications

References 22 publications

Reoperation After Cervical Disc Arthroplasty Versus Anterior Cervical Discectomy and Fusion: A Meta-analysis

Reoperation After Cervical Disc Arthroplasty Versus Anterior Cervical Discectomy and Fusion: A Meta-analysis

Mid- to Long-Term Outcomes of Cervical Disc Arthroplasty versus Anterior Cervical Discectomy and Fusion for Treatment of Symptomatic Cervical Disc Disease: A Systematic Review and Meta-Analysis of Eight Prospective Randomized Controlled Trials

The Fragility of Statistical Findings in Cervical Disc Arthroplasty: a Systematic Review of Randomized Controlled Trials

Contact Info

Product

Resources

About