Indirect meta-analysis comparing clinical outcomes of total cervical disc replacements with fusions for cervical degenerative disc disease

Xu, Bin; Ma, Jianxiong; Tian, Jinhui; Ge, Long; Ma, Xinlong

doi:10.1038/s41598-017-01865-3

Cited by 15 publications

(8 citation statements)

References 46 publications

(139 reference statements)

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“…Compared with ACDF, CDA had fewer secondary surgeries at the adjacent level in our meta‐analysis, which concurred with the findings of Xu et al . Although the definite risk factor for secondary surgery is still controversial, some studies indicate a relationship between the occurrence of adjacent segment degeneration and secondary surgery.…”

Section: Discussionsupporting

confidence: 90%

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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Section: Discussionsupporting

confidence: 90%

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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“…Xu et al provided what they termed an "indirect" meta-analysis using data from 5343 patients in which they estimated the relative effectiveness of each type of 4 different CDA and ACDF procedures, and these authors concluded that any of the total cervical replacement devices were good choices for improving functional outcomes and reducing secondary surgeries in comparison to ACDF. 36 One meta-analysis compared outcomes for patients undergoing single-level versus multilevel TDR and found the outcomes were equally favorable, 39 as did a recent individual study. 2 Similar to the current study, clinical trials of other cervical prostheses have also found that outcomes after two-level CDA were superior to outcomes after twolevel ACDF, including in patients with follow-up through 7 years.…”

Section: Discussionmentioning

confidence: 97%

“…Recent meta-analyses that compare CDA to ACDF are based on the large amount of published clinical trial data now available, although few focus specifically on two-level studies. 14,[34][35][36]38 One meta-analysis included 19 randomized controlled trials involving 4516 cases, the majority single level, with short-and midterm follow-up, and demonstrated better outcomes for CDA than ACDF on a wide variety of measures. 38 A number of other more recent meta-analyses have reported advantages to CDA.…”

Section: Discussionmentioning

confidence: 99%

Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial

Gornet

Lanman

Burkus³

et al. 2019

Journal of Neurosurgery: Spine

102

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OBJECTIVEThe authors assessed the 10-year clinical safety and effectiveness of cervical disc arthroplasty (CDA) to treat degenerative cervical spine disease at 2 adjacent levels compared to anterior cervical discectomy and fusion (ACDF).METHODSA prospective, randomized, controlled, multicenter FDA-approved clinical trial was conducted comparing the low-profile titanium ceramic composite–based Prestige LP Cervical Disc (n = 209) at two levels with ACDF (n = 188). Ten-year follow-up data from a postapproval study were available on 148 CDA and 118 ACDF patients and are reported here. Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at regular postoperative follow-up intervals for up to 10 years. The primary endpoint was overall success, a composite variable that included key safety and efficacy considerations. Ten-year follow-up rates were 86.0% for CDA and 84.9% for ACDF.RESULTSFrom 2 to 10 years, CDA demonstrated statistical superiority over ACDF for overall success, with rates at 10 years of 80.4% versus 62.2%, respectively (posterior probability of superiority [PPS] = 99.9%). Neck Disability Index (NDI) success was also superior, with rates at 10 years of 88.4% versus 76.5% (PPS = 99.5%), as was neurological success (92.6% vs 86.1%; PPS = 95.6%). Improvements from preoperative results in NDI and neck pain scores were consistently statistically superior for CDA compared to ACDF. All other study effectiveness measures were at least noninferior for CDA compared to ACDF through the 10-year follow-up period, including disc height. Mean angular ranges of motion at treated levels were maintained in the CDA group for up to 10 years. The rates of grade IV heterotopic ossification (HO) at the superior and inferior levels were 8.2% and 10.3%, respectively. The rate of severe HO (grade III or IV) did not increase significantly from 7 years (42.4%) to 10 years (39.0%). The CDA group had fewer serious (grade 3–4) implant-related or implant/surgical procedure–related adverse events (3.8% vs 8.1%; posterior mean 95% Bayesian credible interval [BCI] of the log hazard ratio [LHR] −0.92 [−1.88, −0.01]). The CDA group also had statistically fewer secondary surgical procedures at the index levels (4.7%) than the ACDF group (17.6%) (LHR [95% BCI] −1.39 [−2.15, −0.61]) as well as at adjacent levels (9.0% vs 17.9%).CONCLUSIONSThe Prestige LP Cervical Disc, implanted at two adjacent levels, maintains improved clinical outcomes and segmental motion 10 years after surgery and is a safe and effective alternative to fusion.Clinical trial registration no.: NCT00637156 (clinicaltrials.gov)

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“…Dejaegher et al reported in a 10-year follow-up after implantation of another cervical disc prosthesis 186 adverse events recorded for 73 patients, out of 89 included in the study, and 2% rate of reoperation at the index level. It has become common with recent publications to report that CTDRs have significantly lower rates of adverse events and reoperations than ACDF [3,11,13,32].…”

Section: Discussionmentioning

confidence: 99%

“…A large number of arthroplasty devices have been developed [7,10]. Previous published studies have established that CTDR provides pain relief and functional improvements similar or superior to those of ACDF with lower rates of adjacent segment degeneration [11][12][13].…”

Section: Introductionmentioning

confidence: 99%

Clinical and radiological evaluation of cervical disc arthroplasty with 5-year follow-up: a prospective study of 384 patients

Dufour¹,

Beaurain

Huppert

et al. 2019

Eur Spine J

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Background Cervical total disc replacement was developed to avoid known complications of cervical fusion. The purpose of this paper was to provide 5-year follow-up results of an ongoing prospective study after implantation of cervical disc prosthesis. Methods Three hundred and eighty-four patients were treated using Mobi-C cervical disc (Zimmer Biomet, Troyes, France) and included in a prospective multicentre study. Routine clinical and radiological examinations were reported preoperatively and postoperatively with up to 5-year follow-up. Complications and revision surgeries were also explored. Results Results at 5 years showed significant improvement in all clinical outcomes (NDI, VAS for arm and neck pain, SF-36 PCS and MCS). Motion at index level increased significantly from 6.0° preoperatively to 8.0°, and 72.1% of the implanted segments were still mobile (referring to threshold of ROM > 3°). Proximal and distal adjacent discs showed no significant change in average motion 5 years after surgery compared to baseline. Ossification resulting in complete fusion was observed in 16.4% of the implanted segments. Distal and proximal adjacent disc degeneration occurred in 42.2% and 39.1% of patients, respectively. Complications rate was 8.9%, and 1.5% of the patients had reoperation at the index level. Surgery rate of adjacent discs was 2.9%. An increased percentage of working patients and a decrease in medication consumption were observed. At 5 years, 93.3% patients were satisfied regarding the overall outcome. Conclusions In this study, favourable 5-year follow-up clinical and radiological outcomes were observed with a low rate of adjacent level surgery.

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Indirect meta-analysis comparing clinical outcomes of total cervical disc replacements with fusions for cervical degenerative disc disease

Cited by 15 publications

References 46 publications

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

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

Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial

Clinical and radiological evaluation of cervical disc arthroplasty with 5-year follow-up: a prospective study of 384 patients

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