Mid- to long-term rates of symptomatic adjacent-level disease requiring surgery after cervical total disc replacement compared with anterior cervical discectomy and fusion: a meta-analysis of prospective randomized clinical trials

Deng, Yifei; Li, Guangzhou; Líu, Hao; Hong, Ying; Meng, Yang

doi:10.1186/s13018-020-01957-3

Cited by 13 publications

(13 citation statements)

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“…Moreover, in our study, patients who underwent CDA were found to have lower rates of SALDRS. Our findings were consistent with those of previous meta-analyses investigating adjacent segment condition that included mid-term and long-term outcome measures 41–43 . Previous meta-analysis of RCTs with 2- to 5-year follow-up observed no statistically significant difference in the rate of SALDRS between CDA and ACDF groups 43 .…”

Section: Discussionsupporting

confidence: 92%

“…Our findings were consistent with those of previous meta-analyses investigating adjacent segment condition that included mid-term and long-term outcome measures. [41][42][43] Previous meta-analysis of RCTs with 2-to 5-year follow-up observed no statistically significant difference in the rate of SALDRS between CDA and ACDF groups. 43 Our findings agree that at 60-month follow-up, RCTs did not demonstrate any significant difference in the frequency of SALDRS between the 2 groups; however, when we segregated our pooled analysis to 84-month or > 108-month follow-up, we observed that the CDA group exhibited lower rates of SALDRS than the ACDF group.…”

Section: Discussionmentioning

confidence: 97%

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Mid-term and Long-term Outcomes After Total Cervical Disk Arthroplasty Compared With Anterior Cervical Discectomy and Fusion

Kim,

Mazur,

Dailey

2023

Clinical Spine Surgery: A Spine Publication

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Study Design: A meta-analysis of randomized controlled trials (RCTs). Objective: The aim of this study was to compare mid-term to long-term outcomes of cervical disk arthroplasty (CDA) with those of anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic cervical degenerative disk disease. Summary of Background Data: After ACDF to treat symptomatic cervical degenerative disk disease, the loss of motion at the index level due to fusion may accelerate adjacent-level disk degeneration. CDA was developed to preserve motion and reduce the risk of adjacent segment degeneration. Early-term to mid-term clinical outcomes from RCTs suggest noninferiority of CDA compared with ACDF, but it remains unclear whether CDA yields better mid-term to long-term outcomes than ACDF. Materials and Methods: Two independent reviewers searched PubMed, Embase, and the Cochrane Library for RCTs with at least 60 months of follow-up. The risk ratio or standardized mean difference (and 95% CIs) were calculated for dichotomous or continuous variables, respectively. Results: Eighteen reports of 14 RCTs published in 2014–2023 were included. The pooled analysis demonstrated that the CDA group had a significantly greater improvement in neurological success and Neck Disability Index than the ACDF group. The ACDF group exhibited a significantly better improvement in the Short Form-36 Health Survey Physical Component Summary than the CDA group. Radiographic adjacent segment degeneration was significantly lower in the CDA group at 60- and 84-month follow-ups; at 120-month follow-up, there was no significant difference between the 2 groups. Although the overall rate of secondary surgical procedures was significantly lower in the CDA group, we did not observe any significant difference at 60-month follow-up between the CDA and ACDF group and appreciated statistically significant lower rates of radiographic adjacent segment degeneration, and symptomatic adjacent-level disease requiring surgery at 84-month and 108- to 120-month follow-up. The rate of adverse events and the neck and arm pain scores in the CDA group were not significantly different from those of the ACDF group. Conclusions: In this meta-analysis of 14 RCTs with 5- to 10-year follow-up data, CDA resulted in significantly better neurological success and Neck Disability Index scores and lower rates of radiographic adjacent segment degeneration, secondary surgical procedures, and symptomatic adjacent-level disease requiring surgery than ACDF. ACDF resulted in improved Short Form-36 Health Survey Physical Component Summary scores. However, the CDA and ACDF groups did not exhibit significant differences in overall changes in neck and arm pain scores or rates of adverse events.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionmentioning

confidence: 97%

Mid-term and Long-term Outcomes After Total Cervical Disk Arthroplasty Compared With Anterior Cervical Discectomy and Fusion

Kim,

Mazur,

Dailey

2023

Clinical Spine Surgery: A Spine Publication

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“…Most recently, Deng et al performed meta-analysis on 8 RCTs with follow-up of >48 months. 40 Their analysis included 1334 patients with CDA and 1061 patients treated with ACDF. They reported overall CASP of 3.6% for CDA and 9.5% for ACDF (OR = 0.38; 95% CI = 0.27, 0.53; P < 0.0001).…”

Section: Adjacent-segment Pathologymentioning

confidence: 99%

Cervical Disc Arthroplasty vs Anterior Cervical Discectomy and Fusion at 10 Years: Results From a Prospective, Randomized Clinical Trial at 3 Sites

et al. 2023

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Background: Over the past 20 years, multiple randomized controlled trials have shown cervical disc arthroplasty (CDA) to be safe and effective for treating 1-and 2-level degenerative disc disease (DDD). The purpose of this postmarket study is to compare 10-year outcomes between CDA and anterior cervical discectomy and fusion (ACDF) from a randomized study at 3 centers.Methods: This study was a continuation of a randomized, prospective, multicenter clinical trial comparing CDA with the Mobi-C cervical disc (Zimmer Biomet) vs ACDF. Following completion of the 7-year US Food and Drug Administration study, 10-year follow-up was obtained from consenting patients at 3 high-enrolling centers. The clinical and radiographic endpoints collected at 10 years included composite success, Neck Disability Index, neck and arm pain, short form-12, patient satisfaction, adjacent-segment pathology, major complications, and subsequent surgery.Results: A total of 155 patients were enrolled (105 CDA; 50 ACDF). Follow-up was obtained from 78.1% of patients eligible after 7 years. At 10 years, CDA demonstrated superiority to ACDF. Composite success was 62.4% in CDA and 22.2% in ACDF (P < 0.0001). The cumulative risk of subsequent surgery at 10 years was 7.2% vs 25.5% (P = .001), and the risk of adjacent-level surgery was 3.1% vs 20.5% (P = .0005) in CDA vs ACDF, respectively. The progression to radiographically significant adjacent-segment pathology at 10 years was lower in CDA vs ACDF (12.9% vs 39.3%; P = 0.006). At 10 years, patient-reported outcomes and change from baseline were generally better in CDA patients. A higher percentage of CDA patients reported they were "very satisfied" at 10 years (98.7% vs 88.9%; P = 0.05).Conclusions: In this postmarket study, CDA was superior to ACDF for treating symptomatic cervical DDD. CDA was statistically superior to ACDF for clinical success, subsequent surgery, and neurologic success. Results through 10 years demonstrate that CDA continues to be a safe and effective surgical alternative to fusion.Clinical Relevance: The results of this study support the long-term safety and effectiveness of cervical disc arthroplasty with the Mobi-C.Level of Evidence: 1.

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“…In all series, index level revision surgery was less frequent after CDA and CDA may have superior longevity compared with ACDF regarding both index, and adjacent level, revision operations. 16,44,45,[48][49][50][51] Limitations to this study include the absence of control patients with ACDF, but we excluded no cases and followed all individuals consecutively. The first cases under the learning curve, the work-related injury patients, and the 14% of patients who had undergone previous cervical surgery might have unfavorably biased our results.…”

Section: Cervical Spinementioning

confidence: 99%

Observational, Multicenter Study of the Efficacy and Safety of Cervical Disk Arthroplasty With Mobi-C in the Treatment of Cervical Degenerative Disk Disease. Results at 10 years Follow-Up

Steib

Dufour²,

Beaurain

et al. 2022

Spine

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Background. Cervical disk arthroplasty replacement (CDA) was developed to avoid specific disadvantages of cervical fusion. The purpose of this paper is to provide 10-year follow-up results of an ongoing prospective study after CDA. Methods. Three hundred eighty-four patients treated using the Mobi-C (ZimVie, Troyes, France) were included in a prospective multicenter study. Routine clinical and radiologic examinations were reported preoperatively and postoperatively with up to 10-year follow-up. Complications and revision surgeries were also documented.Results. At 10 years showed significant improvement in all clinical outcomes [Neck Disability Index, visual analog scale (VAS) for arm and neck pain, physical component summary of SF36, and mental component summary of SF36). Motion at the index level increased significantly over baseline (mean range of motion = 7.6 vs. 8 degrees at five years and 6.0 degrees preoperatively; P < 0.001) and 71.3% of the implanted segments remained mobile (range of motion > 3 degrees). Adjacent disks were also mobile at 10 years with the same mobility as preoperatively. At 10 years, 20.9% of the implanted segments demonstrated no heterotopic ossification. Thirty-four patients (8.9%) experienced 41 adverse events, with or without reoperation during the first five years. We found only two additional surgeries after five years. We observed an increased percentage of working patients and a decrease in medication consumption. Regarding the overall outcome, 94% of patients were satisfied. Conclusions. Our 10-year results showed significant improvement in all clinical outcomes, with low rates of revision or failure. This experience in patients with long-term follow-up after CDA endorses durable, favorable outcomes in properly selected patients.

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Mid- to long-term rates of symptomatic adjacent-level disease requiring surgery after cervical total disc replacement compared with anterior cervical discectomy and fusion: a meta-analysis of prospective randomized clinical trials

Cited by 13 publications

References 50 publications

Mid-term and Long-term Outcomes After Total Cervical Disk Arthroplasty Compared With Anterior Cervical Discectomy and Fusion

Mid-term and Long-term Outcomes After Total Cervical Disk Arthroplasty Compared With Anterior Cervical Discectomy and Fusion

Cervical Disc Arthroplasty vs Anterior Cervical Discectomy and Fusion at 10 Years: Results From a Prospective, Randomized Clinical Trial at 3 Sites

Observational, Multicenter Study of the Efficacy and Safety of Cervical Disk Arthroplasty With Mobi-C in the Treatment of Cervical Degenerative Disk Disease. Results at 10 years Follow-Up

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