Effectiveness and safety of Mobi-C for treatment of single-level cervical disc spondylosis

Hou, Yong; Lin, Na; Pan, Xin; Si, Meng; Han, Yong-bin; Li, J; Zhang, H

doi:10.1302/0301-620x.98b6.36381

Cited by 39 publications

(41 citation statements)

References 23 publications

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“…A total of 814 studies were removed because they were duplicates, 1076 studies were excluded based on their titles and abstracts, and 43 studies were excluded for other reasons. As a result, 21 studies were included for further evaluation. Among them, 2 studies were partial results of multicenter RCT and 8 studies included duplicated data for publication.…”

Section: Resultsmentioning

confidence: 99%

“…In addition, all included RCT failed to achieve blinding to patients and care providers due to the specialty of this kind of trial. The patients were informed immediately after surgery about the type of surgical procedure they had been underwent, and care providers were aware of which kind of surgery was to be performed during surgery. Almost all the studies described the dropout rate and 2 studies with a follow‐up rate below 70% were considered as having high risk of bias.…”

Section: Resultsmentioning

confidence: 99%

“…Then, we performed sensitivity analysis based on the leave‐one‐out method. For NDI score, we found that the combined result changed significantly when removing the study from Hou et al . or MacDowall et al ,.…”

Section: Resultsmentioning

confidence: 99%

“…Heterogeneity definitely existed in the included studies. First, various different types of CDA devices were used in the 11 RCT, including Kineflex|C, Bryan, Discover Secure‐C, Prestige, Mobi‐C, ProDisc‐C, and PCM, differing in design and biomechanical properties. Second, the surgical level was different among studies.…”

Section: Discussionmentioning

confidence: 99%

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Long‐term Results Comparing Cervical Disc Arthroplasty to Anterior Cervical Discectomy and Fusion: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials

Wang

et al. 2019

Orthopaedic Surgery

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Objective Whether cervical disc arthroplasty (CDA) is superior to anterior cervical discectomy and fusion (ACDF) remains controversial, especially in relation to long‐term results. The present study aimed to evaluate the long‐term safety and efficiency of CDA and ACDF for cervical disc disease. Methods We performed this study according to the Cochrane methodology. An extensive search was undertaken in PubMed, Embase, and Cochrane databases up to 1 June 2019 using the following key words: “anterior cervical fusion,” “arthroplasty,” “replacement” and “artificial disc”. RevMan 5.3 (Cochrane, London, UK) was used to analyze data. Safety and efficiency outcome measures included the success rate, functional outcome measures, adverse events (AE), adjacent segment degeneration (ASD), secondary surgery, and patients’ satisfaction and recommendation rates. The OR and MD with 95% confidence interval (CI) were used to evaluate discontinuous and continuous variables, respectively. The statistically significant level was set at P < 0.05. Results A total of 11 randomized controlled trials with 3505 patients (CDA/ACDF: 1913/1592) were included in this meta‐analysis. Compared with ACDF, CDA achieved significantly higher overall success (2.10, 95% CI [1.70, 2.59]), neck disability index (NDI) success (1.73, 95% CI [1.37, 2.18]), neurological success (1.65, 95% CI [1.24, 2.20]), patients’ satisfaction (2.14, 95% CI [1.50, 3.05]), and patients’ recommendation rates (3.23, 95% CI [1.79, 5.80]). Functional outcome measures such as visual analog score neck pain (−5.50, 95% CI [−8.49, −2.52]) and arm pain (−3.78, 95% CI [−7.04, −0.53]), the Short Form‐36 physical component score (SF‐36 PCS) (1.93, 95% CI [0.53, 3.32]), and the Short Form‐36 mental component score (SF‐36 MCS) (2.62, 95% CI [0.95, 4.29]), revealed superiority in the CDA group. CDA also achieved a significantly lower rate of symptomatic ASD (0.46, 95% CI [0.34, 0.63]), total secondary surgery (0.50, 95% CI [0.29, 0.87]), secondary surgery at the index level (0.46, 95% CI [0.29, 0.74]), and secondary surgery at the adjacent level (0.37, 95% CI [0.28, 0.49]). However, no significant difference was found in radiological success (1.35, 95% CI [0.88, 2.08]), NDI score (−2.88, 95% CI [−5.93, 0.17]), total reported AE (1.14, 95% CI [0.92, 1.42]), serious AE (0.89, 95% CI [0.71, 1.11]), device/surgery‐related AE (0.90, 95% CI [0.68, 1.18]), radiological superior ASD (0.63, 95% CI [0.28, 1.43]), inferior ASD (0.45, 95% CI [0.19, 1.11]), and work status (1.33, 95% CI [0.78, 2.25]). Furthermore, subgroup analysis showed different results between US and non‐US groups. Conclusion Our study provided further evidence that compared to ACDF, CDA had a higher long‐term clinical success rate and better functional outcome measurements, and resulted in less symptomatic ASD and fewer secondary surgeries. However, worldwide multicenter RCT with long‐term follow up are still needed for further evaluation in the future.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Long‐term Results Comparing Cervical Disc Arthroplasty to Anterior Cervical Discectomy and Fusion: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials

Wang

et al. 2019

Orthopaedic Surgery

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“…Several studies have compared the effectiveness and safety of ACDF and CDA for the treatment of cervical degenerative disc disease, and most of the results demonstrate that CDA is similar to ACDF, or even better in regard to some clinical and radiographic outcomes. However, most of those studies were evaluated as low quality, and may overestimate the effectiveness of CDA. In addition, a meta‐analysis conducted by Zhang et al .…”

Section: Introductionmentioning

confidence: 97%

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

Zhu¹,

Kan²,

Cao³

et al. 2018

Orthopaedic Surgery

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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 < 0.05) and adjacent level (RR, 0.48; 95%CI, 0.36-0.65; P < 0.05), and the differences were statistically significant. In addition, in terms of the overall frequency of secondary surgery at the index and adjacent level, CDA was also significantly superior to ACDF (RR, 0.49; 95%CI, 0.41-0.60; P < 0.05). TSA demonstrated that adequate and decisive evidence had been established. Regarding the frequency of secondary surgery, CDA was significantly superior to ACDF. It was supposed that CDA may be a better surgical intervention to reduce the rate of secondary surgery for patients with cervical degenerative disc disease.

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Cervical radiculopathy: is a prosthesis preferred over fusion surgery? A systematic review

et al. 2019

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Background Meta-analyses on the comparison between fusion and prosthesis in the treatment of cervical radiculopathy mainly analyse studies including mixed patient populations: patients with radiculopathy with and without myelopathy. The outcome for patients with myelopathy is different compared to those without. Furthermore, apart from decompression of the spinal cord, restriction of motion is one of the cornerstones of the surgical treatment of spondylotic myelopathy. From this point of view, the results for arthroplasty might be suboptimal for this category of patients. Comparing clinical outcome in patients exclusively suffering from radiculopathy is therefore a more valid method to compare the true clinical effect of the prosthesis to that of fusion surgery. Aim The objective of this study was to compare clinical outcome of cervical arthroplasty (ACDA) to the clinical outcome of fusion (ACDF) after anterior cervical discectomy in patients exclusively suffering from radiculopathy, and to evaluate differences with mixed patient populations. Methods A literature search was completed in PubMed, EMBASE, Web of Science, COCHRANE, CENTRAL and CINAHL using a sensitive search strategy. Studies were selected by predefined selection criteria (i.a.) patients exclusively suffering from cervical radiculopathy), and risk of bias was assessed using a validated Cochrane Checklist adjusted for this purpose. An additional overview of results was added from articles considering a mix of patients suffering from myelopathy with or without radiculopathy. Results Eight studies were included that exclusively compared intervertebral devices in radiculopathy patients. Additionally, 29 articles concerning patients with myelopathy with or without radiculopathy were studied in a separate results table. All articles showed intermediate to high risk of bias. There was neither a difference in decrease in mean NDI score between the prosthesis (20.6 points) and the fusion (20.3 points) group, nor was there a clinically important difference in neck pain (VAS). Comparing these data to the mixed population data demonstrated comparable mean values, except for the 2-year follow-up NDI values in the prosthesis group: mixed group patients that received a prosthesis reported a mean NDI score Electronic supplementary material The online version of this article (

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Effectiveness and safety of Mobi-C for treatment of single-level cervical disc spondylosis

Abstract: Mobi-C implant surgery is a safe alternative to ACDF surgery in cervical disc degeneration. Cite this article: Bone Joint J 2016;98-B:829-3.

Cited by 39 publications

References 23 publications

Long‐term Results Comparing Cervical Disc Arthroplasty to Anterior Cervical Discectomy and Fusion: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials

Long‐term Results Comparing Cervical Disc Arthroplasty to Anterior Cervical Discectomy and Fusion: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials

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

Cervical radiculopathy: is a prosthesis preferred over fusion surgery? A systematic review

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