Long-Term Clinical Experience with Selectively Constrained SECURE-C Cervical Artificial Disc for 1-Level Cervical Disc Disease: Results from Seven-Year Follow-Up of a Prospective, Randomized, Controlled Investigational Device Exemption Clinical Trial

Vaccaro, Alexander R.; Beutler, William; Peppelman, Walter; Marzluff, Joseph; Mugglin, Andrew S.; Ramakrishnan, Prem S.; Myer, Jacqueline; Baker, Kelly

doi:10.14444/5044

Cited by 66 publications

(61 citation statements)

References 36 publications

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“…. Nine studies were adequately randomized, but 1 study did not provide detailed information of randomization, and 1 study failed to achieve adequate randomization. Only 4 studies provided a clear statement regarding avoiding allocation concealment.…”

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%

“…Among them, 2 studies 45,47 were partial results of multicenter RCT and 8 studies [39][40][41][42][43][44]46,48 included duplicated data for publication. Ultimately, 11 articles [28][29][30][31][32][33][34][35][36][37][38] involving 3505 patients (CDA/ACDF: 1913/1592) were included in this meta-analysis. There are 923 male and 990 female patients in the CDA group and 791 male and 801 female patients in the ACDF group.…”

Section: Literature Reviewmentioning

confidence: 99%

“…The basic characteristics of the included studies and patients are summarized in Table 1. Among them, 8 studies [28][29][30][32][33][34]36,38 compared single-level CDD, 1 study 31 compared two-level CDD, and 2 studies 35,37 compared both single-level and two-level CDD independently.…”

Section: Literature Reviewmentioning

confidence: 99%

“…Only 4 studies 30,32,33,35 provided a clear statement regarding avoiding allocation concealment. In addition, all included RCT [28][29][30][31][32][33][34][35][36][37][38] 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 28,[30][31][32][33][34][35][36][37] .…”

Section: Quality Assessment Of the Included Studiesmentioning

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%