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Secondary Surgery after Cervical Disc Arthroplasty versus Fusion for Cervical Degenerative Disc Disease: A Meta-analysis with Trial Sequential Analysis.

ABSTRACT: The purpose of this meta-analysis was to explore whether cervical disc arthroplasty (CDA) was superior to anterior cervical discectomy and fusion (ACDF) in reducing secondary surgery. PubMed, EMBASE, and the Cochrane Library databases were systematically searched. Outcomes were reported as relative risk (RR) with the corresponding 95% confidence interval (CI). The pooled data was calculated using a random-effect model. We also used the trial sequential analysis (TSA) to further verify our results and obtain more moderate estimates. Twenty-one studies with 4208 patients were included in this meta-analysis. The results indicated that compared with ACDF, CDA had fewer frequency of secondary surgery at the index level (RR, 0.47; 95%CI, 0.36-0.63; P?

SUBMITTER: Zhu RS

PROVIDER: S-EPMC6594473 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Secondary Surgery after Cervical Disc Arthroplasty versus Fusion for Cervical Degenerative Disc Disease: A Meta-analysis with Trial Sequential Analysis.

Zhu Ru-Sen RS Kan Shun-Li SL Cao Ze-Gang ZG Jiang Ze-Hua ZH Zhang Xue-Li XL Hu Wei W

Orthopaedic surgery 20180801 3

The purpose of this meta-analysis was to explore whether cervical disc arthroplasty (CDA) was superior to anterior cervical discectomy and fusion (ACDF) in reducing secondary surgery. PubMed, EMBASE, and the Cochrane Library databases were systematically searched. Outcomes were reported as relative risk (RR) with the corresponding 95% confidence interval (CI). The pooled data was calculated using a random-effect model. We also used the trial sequential analysis (TSA) to further verify our result ...[more]

PMID: 30152612

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Project description:BackgroundAnterior 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/purposesWe 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.MethodsPubMed, 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 no-difference studies may have been performed but have not been published, and so were not identified and included in this meta-analysis.ResultsThe 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, 0.37-0.68; p < 0.001) and adjacent levels (RR, 0.52; 95% CI, 0.37-0.74; p < 0.001).ConclusionsCervical disc arthroplasty is associated with fewer reoperations than anterior cervical discectomy and fusion, indicating that it is a safe and effective alternative to fusion for cervical radiculopathy and myelopathy. However, because of some limitations, these findings should be interpreted with caution. Additional studies are needed.Level of evidenceLevel I, therapeutic study.

Project description:BackgroundCervical disc arthroplasty (CDA) has emerged as an alternative to anterior cervical discectomy and fusion (ACDF) for the treatment of cervical pathologies. Studies are on-going to assess the long term outcomes of CDA. This study assessed the safety and efficacy of the Prestige(®) LP Disc at 84-months follow up.MethodsProspective data from 280 CDA patients with single-level cervical disc disease with radiculopathy or myelopathy were compared with 265 historical control ACDF patients. Clinical and radiographic follow up was completed pre-operatively, intraoperatively, and at intervals up to 84 months.ResultsFollow-up rate was 75.9% for CDA and 70.0% for ACDF patients. Statistical improvements (p < 0.001) in Neck Disability Index (NDI), neck/arm pain, and SF-36 were achieved by 1.5 months in both groups and maintained through 84 months. At 84 months, 86.1% of CDA versus 80.1% of ACDF patients achieved NDI success, (≥15-point improvement over baseline). Mean NDI score improvements exceeded 30 points in both groups. SF-36 PCS/MCS mean improvements were 13.1±11.9/8.2±12.3 points for CDA and 10.7±11.8/8.3±13.6 points for ACDF. Neurological success was 92.8% for CDA and 79.7% for ACDF patients. The rate of Overall Success was 74.9% for CDA and 63.2% for ACDF. At 84 months, 17.5% of CDA and 16.6% of ACDF patients had a possibly implant- or implant-surgical procedure-related adverse event. Eighteen (6.4%) CDA and 29 (10.9%) ACDF patients had a second surgery at the index level. In CDA patients, mean angular motion at the target level was maintained at 24 (7.5°) and 84 (6.9°) months. Bridging bone was reported in 5.9%/9.5%/10.2%/13.0% of CDA patients at 24/36/60/84 months. Change in mean preoperative angulation of the adjacent segment above/below the index level was1.06±4.39/1.25±4.06 for CDA and (-0.23)±5.37/1.25±5.07 for ACDF patients. At 84 months, 90.9% of CDA and 85.6% of ACDF patients were satisfied with the results of their treatment.ConclusionsPrestige LP maintained significantly improved clinical outcomes and segmental motion; statistical superiority of CDA was concluded for overall success. This investigational device exemption study was sponsored by Medtronic Spinal and Biologics, Memphis, TN. Study approved by the Hughston Sports Medicine Center Institutional Review Board on January 7, 2005. Clinical trial registered at clinicaltrials.gov: NCT00667459. All participants signed an informed consent.

Project description:IntroductionTo date, there is no consensus on which anterior surgical technique is more cost-effective in treating cervical degenerative disc disease (CDDD). The most commonly used surgical treatment for patients with single- or multi-level symptomatic CDDD is anterior cervical discectomy with fusion (ACDF). However, new complaints of radiculopathy and/or myelopathy commonly develop at adjacent levels, also known as clinical adjacent segment pathology (CASP). The extent to which kinematics, surgery-induced fusion, natural history, and progression of disease play a role in the development of CASP remains unclear. Anterior cervical discectomy with arthroplasty (ACDA) is another treatment option that is thought to reduce the incidence of CASP by preserving motion in the operated segment. While ACDA is often discouraged, as the implant costs are higher while the clinical outcomes are similar to ACDF, preventing CASP might be a reason for ACDA to be a more cost-effective technique in the long term.Methods and analysisIn this randomized controlled trial, patients will be randomized to receive ACDF or ACDA in a 1:1 ratio. Adult patients with single- or multi-level CDDD and symptoms of radiculopathy and/or myelopathy will be included. The primary outcome is cost-effectiveness and cost-utility of both techniques from a healthcare and societal perspective. Secondary objectives are the differences in clinical and radiological outcomes between the two techniques, as well as the qualitative process surrounding anterior decompression surgery. All outcomes will be measured at baseline and every 6 months until 4 years post-surgery.DiscussionHigh-quality evidence regarding the cost-effectiveness of both ACDA and ACDF is lacking; to date, there are no prospective trials from a societal perspective. Considering the aging of the population and the rising healthcare costs, there is an urgent need for a solid clinical cost-effectiveness trial addressing this question.Trial registrationClinicalTrials.gov NCT04623593. Registered on 29 September 2020.

Project description:BackgroundAnterior cervical discectomy and fusion (ACDF) and cervical disc arthroplasty (CDA) have been used to treat degenerative disc disease at single as well as multiple cervical levels. This study compares the safety and efficacy of 1-level versus 2-level CDA and ACDF.MethodsIn total, 545 and 397 patients with degenerative disc disease were studied in 1-level and 2-level Food and Drug Administration (FDA)-approved clinical trials, respectively: CDA (n = 280 and 209), ACDF (n = 265 and 188). Data from these studies were used to compare 1- versus 2-level procedures: the propensity score method was used to adjust for potential confounding effects, and adjusted mean outcome safety and efficacy scores at 2 and 7 years postsurgery were compared between 1-level and 2-level procedures within treatment type.ResultsOne-level and 2-level procedures had similar rates of improvement in overall success and patient-reported outcomes scores for both CDA and ACDF. There were no statistical differences in rates of implant-related adverse events (AEs) or serious implant-related AEs between 1-level and 2-level CDA. The 7-year rate of implant-related AEs was higher for 2-level than 1-level ACDF (27.7% vs 18.9%, P ≤ .036), though the rates of serious implant-related AEs between ACDF groups did not differ significantly. Secondary surgery rates were not statistically different between 1-level and 2-level procedures (CDA or ACDF) at the index or adjacent levels at 2 or 7 years. Grade IV heterotopic ossification at 7 years was reported in 4.6% of 1-level CDA patients and 8.6%/7.3% at the superior/inferior levels, respectively, of 2-level CDA patients.ConclusionsOne- and 2-level CDA appear equally safe and effective in the treatment of cervical degenerative disc disease. Two-level ACDF appears to be as effective as 1-level ACDF but with a higher rate of some AEs at long-term follow-up.Level of evidence2.Clinical trialsclinicaltrials.gov: NCT00667459, NCT00642876, and NCT00637156.

Dataset Information

Secondary Surgery after Cervical Disc Arthroplasty versus Fusion for Cervical Degenerative Disc Disease: A Meta-analysis with Trial Sequential Analysis.

Publications

Secondary Surgery after Cervical Disc Arthroplasty versus Fusion for Cervical Degenerative Disc Disease: A Meta-analysis with Trial Sequential Analysis.

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