Superiority of the Bryan® Disc Prosthesis for Cervical Myelopathy: A Randomized Study with 3-year Followup

Cheng, Lei; Lin, Na; Li, Mu; Huo, Yong; Pan, Xin

doi:10.1007/s11999-011-2039-z

Cited by 61 publications

(54 citation statements)

References 23 publications

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“…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%

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

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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-

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Section: Discussionmentioning

confidence: 99%

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

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“…11 Complication rates were higher in the ACDF group since dysphagia was seen in 7 patients as compared to only 1 in the Bryan group (p < 0.001).…”

Section: 63mentioning

confidence: 83%

“…These studies were designed to compare the efficacy and complication rates between 2 different surgical interventions or varying techniques. Studies reported on differences between anterior and posterior approaches (n = 9); 15,18,19,22,30,42,44,48,59 laminoplasty and laminectomy and fusion (n = 4); 10,19,70,72 anterior decompression and Bryan disc (n = 1); 11 and anterior cervical discectomy and fusion (ACDF) and corpectomy (n = 2). 47,63 In addition, 11 studies compared laminoplasty techniques or considered technical differences such as laminoplasty with and without foraminotomy or muscle preservation.…”

Section: Study Characteristicsmentioning

confidence: 99%

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A systematic review of clinical and surgical predictors of complications following surgery for degenerative cervical myelopathy

Tetreault

Ibrahim

Côté

et al. 2016

SPI

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OBJECT Although generally safe and effective, surgery for the treatment of cervical spondylotic myelopathy (CSM) is associated with complications in 11%–38% of patients. Several predictors of postoperative complications have been proposed but few are used to detect high-risk patients. A standard approach to identifying “at-risk” patients would improve surgeons’ ability to prevent and manage these complications. The authors aimed to compare the complication rates between various surgical procedures used to treat CSM and to identify patient-specific, clinical, imaging, and surgical predictors of complications. METHODS The authors conducted a systematic review of the literature and searched MEDLINE, MEDLINE in Process, EMBASE, and Cochrane Central Register of Controlled Trials from 1948 to September 2013. Cohort studies designed to evaluate predictors of complications and intervention studies conducted to compare different surgical approaches were included. Each article was critically appraised independently by 2 reviewers, and the evidence was synthesized according to the principles outlined by the Grading of Recommendation Assessment, Development and Evaluation (GRADE) Working Group. RESULTS A total of 5472 citations were retrieved. Of those, 60 studies met the inclusion criteria and were included in the review. These studies included 36 prognostic cohort studies and 28 comparative intervention studies. High evidence suggests that older patients are at a greater risk of perioperative complications. Based on low evidence, other clinical factors such as body mass index, smoking status, duration of symptoms, and baseline severity score, are not predictive of complications. With respect to surgical factors, low to moderate evidence suggests that estimated blood loss, surgical approach, and number of levels do not affect rates of complications. A longer operative duration (moderate evidence), however, is predictive of perioperative complications and a 2-stage surgery is related to an increased risk of major complications (high evidence). In terms of surgical techniques, higher rates of neck pain were found in patients undergoing laminoplasty compared with anterior spinal fusion (moderate evidence). In addition, with respect to laminoplasty techniques, there was a lower incidence of C-5 palsy in laminoplasty with concurrent foraminotomy compared with nonforaminotomy (low evidence). CONCLUSIONS The current review suggests that older patients are at a higher risk of perioperative complications. A longer operative duration and a 2-stage surgery both reflect increased case complexity and can indirectly predict perioperative complications.

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“…The authors concluded that the arthroplasty group had fewer complications and that the results were superior to those obtained with fusion at follow-up. 6 Due to the small sample size and retrospective study design, one must be very cautious in interpreting these results, however, and it is well accepted that ACDF is an effective surgical management of multilevel cervical DDD causing CSM. 7,8,13,16,23 In the present study, the authors have demonstrated that the use of arthroplasty for the management of cervical DDD involving more than one vertebral level and causing myelopathy is equally effective as for radiculopathy.…”

Section: Discussionmentioning

confidence: 99%

Arthroplasty for cervical spondylotic myelopathy: similar results to patients with only radiculopathy at 3 years' follow-up

Fay

Huang

et al. 2014

SPI

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Object Cervical arthroplasty has been accepted as a viable option for surgical management of cervical spondylosis or degenerative disc disease (DDD). The best candidates for cervical arthroplasty are young patients who have radiculopathy caused by herniated disc with competent facet joints. However, it remains uncertain whether arthroplasty is equally effective for patients who have cervical myelopathy caused by DDD. The aim of this study was to compare the outcomes of arthroplasty for patients with cervical spondylotic myelopathy (CSM) and patients with radiculopathy without CSM. Methods A total of 151 consecutive cases involving patients with CSM or radiculopathy caused by DDD and who underwent one- or two-level cervical arthroplasty were included in this study. Clinical outcome evaluations and radiographic studies were reviewed. Clinical outcome measurements included the Visual Analog Scale (VAS) of neck and arm pain, Japanese Orthopaedic Association (JOA) scores, and the Neck Disability Index (NDI) in every patient. For patients with CSM, Nurick scores were recorded for evaluation of cervical myelopathy. Radiographic studies included lateral dynamic radiographs and CT for detection of the formation of heterotopic ossification . Results Of the 151 consecutive patients with cervical DDD, 125 (82.8%; 72 patients in the myelopathy group and 53 in the radiculopathy group) had at least 24 months of clinical and radiographic follow-up. The mean duration of follow-up in these patients was 36.4 months (range 24–56 months). There was no difference in sex distribution between the 2 groups. However, the mean age of the patients in the myelopathy group was approximately 6 years greater than that of the radiculopathy group (53.1 vs 47.2 years, p < 0.001). The mean operation time, mean estimated blood loss, and the percentage of patients prescribed perioperative analgesic agents were similar in both groups (p = 0.754, 0.652, and 0.113, respectively). There were significant improvements in VAS neck and arm pain, JOA scores, and NDI in both groups. Nurick scores in the myelopathy group also improved significantly after surgery. In radiographic evaluations, 92.5% of patients in the radiculopathy group and 95.8% of those in the radiculopathy group retained spinal motion (no significant difference). Evaluation of CT scans showed heterotopic ossification in 34 patients (47.2%) in the myelopathy group and 25 patients (47.1%) in the radiculopathy group (p = 0.995). At a mean of over 3 years postoperatively, no secondary surgery was reported in either group. Conclusions The severity of myelopathy improves after cervical arthroplasty in patients with CSM caused by DDD. At 3-year follow-up, the clinical and radiographic outcomes of cervical arthroplasty in DDD patients with CSM are similar to those patients who have only cervical radiculopathy. Therefore, cervical arthroplasty is a viable option for patients with CSM caused by DDD who require anterior surgery. However, comparison with the standard surgical treatment of anterior cervical discectomy and fusion is necessary to corroborate the outcomes of arthroplasty for CSM.

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Superiority of the Bryan® Disc Prosthesis for Cervical Myelopathy: A Randomized Study with 3-year Followup

Cited by 61 publications

References 23 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

A systematic review of clinical and surgical predictors of complications following surgery for degenerative cervical myelopathy

Arthroplasty for cervical spondylotic myelopathy: similar results to patients with only radiculopathy at 3 years' follow-up

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