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Cervical spine kinematics after anterior cervical discectomy with or without implantation of a mobile cervical disc prosthesis; an RCT.

ABSTRACT: When surgically treating cervical degenerative disc disease, the most commonly performed procedure is anterior cervical discectomy. This procedure is performed with, or without fusion promoting methods. For both options the rate of fusion is high and there is much debate whether fusion of the treated segment is a contributing factor to accelerated degeneration of adjacent motion segments. In an effort to prevent degeneration of adjacent segments (ASDeg) due to loss of mobility at the operated level, cervical disc arthroplasty (CDA) was introduced. To evaluate the effectiveness of CDA in preventing ASDeg long term studies are necessary. However, prevention of ASDeg is based on the premise that mobile disc prostheses preserve cervical spine motion in a physiological way. In this article the authors describe a short term protocol for a study that aims to investigate whether CDA reaches the intended goal: restoration or preservation of physiological cervical spine motion. To this end, a technique is used to establish the sequence of contributions of cervical motion segments to flexion/extension of the spine.24 subjects between 18 and 55 years old, with radicular symptoms due to a herniated disc between C5 and C7, refractory to conservative therapy are randomized to simple discectomy, or CDA. These groups are preceded by a pilot group of three subjects receiving CDA. Fluoroscopic flexion-extension recordings are acquired preoperatively, and at three and 12 months postoperative. At these same time points, patient reported outcomes are collected, and a neurological examination is performed by and independent physician.Studies investigating arthroplasty determine mobility by measuring segmental range of motion (sROM), which gives no information other than presence, and quantity, of mobility. SROM suffer from high variability. The authors therefore chose to use a method previously used in healthy controls, to describe the dynamic process of cervical spine motion in more detail. Determining cervical spine motion patterns has been reported to be more consistent than sROM. If a physiological motion pattern is absent after surgery in the CDA group, prevention of future ASDeg is less likely. Radiological outcomes will be correlated to clinical outcomes.NCT00868335.

SUBMITTER: Boselie TF

PROVIDER: S-EPMC4349598 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature

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Cervical spine kinematics after anterior cervical discectomy with or without implantation of a mobile cervical disc prosthesis; an RCT.

Boselie Toon F M TF van Mameren Henk H de Bie Rob A RA van Santbrink Henk H

BMC musculoskeletal disorders 20150221

<h4>Background</h4>When surgically treating cervical degenerative disc disease, the most commonly performed procedure is anterior cervical discectomy. This procedure is performed with, or without fusion promoting methods. For both options the rate of fusion is high and there is much debate whether fusion of the treated segment is a contributing factor to accelerated degeneration of adjacent motion segments. In an effort to prevent degeneration of adjacent segments (ASDeg) due to loss of mobility ...[more]

PMID: 25887569

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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: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.

Dataset Information

Cervical spine kinematics after anterior cervical discectomy with or without implantation of a mobile cervical disc prosthesis; an RCT.

Publications

Cervical spine kinematics after anterior cervical discectomy with or without implantation of a mobile cervical disc prosthesis; an RCT.

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