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      Safety and efficacy of cervical disc arthroplasty in preventing the adjacent segment disease: a meta-analysis of mid- to long-term outcomes in prospective, randomized, controlled multicenter studies

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          Abstract

          Objectives

          Cervical disc arthroplasty (CDA) has become an alternative treatment for cervical radiculopathy and myelopathy. This technique preserves appropriate motion at both the index and adjacent disc levels and consequently may prevent adjacent segment degeneration (ASD). The authors performed a meta-analysis to compare the safety and efficacy of CDA to those of the gold standard, anterior cervical discectomy and fusion (ACDF). Both surgical and clinical parameters were employed to verify the hypothesis that CDA can reduce the risk of ASD.

          Methods

          The meta-analysis comprised high-quality randomized controlled trials that compared CDA and ACDF treatments of cervical degenerative disc disease. Included papers reported data for at least one of the following outcomes: 1) surgical parameters, 2) questionnaire clinical indices (pre- and postoperative values), and 3) complication rates at 24 months; in addition, for ASD we analyzed 60 month or longer follow-ups. We used mean differences (MDs) or ORs to compare treatment effects between CDA and ACDF.

          Results

          Twenty studies with 3,656 patients (2,140 with CDA and 1,516 with ACDF) met the inclusion criteria. CDA surgery, with mean duration longer than that of ACDF, was associated with higher blood loss. Visual analog scale neck pain score was significantly smaller for CDA (mean difference =−2.30, 95% CI [−3.72; −0.87], P=0.002). The frequency of dysphagia/dysphonia (OR =0.69, 95% CI [0.49; 0.98], P=0.04) as well as the long-term ASD rate for CDA was significantly smaller (OR =0.33, 95% CI [0.21; 0.50], P<0.0001).

          Conclusion

          A significantly lower probability of ASD reoperations in the CDA cohort after a 60-month or longer follow-up was the most important finding of this study. Despite the moderate quality of this evidence, the pooled data corroborated for the very first time that CDA was efficacious in preventing ASD.

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          Most cited references 46

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          Meta: an R package for meta‐analysis

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            Results of the prospective, randomized, controlled multicenter Food and Drug Administration investigational device exemption study of the ProDisc-C total disc replacement versus anterior discectomy and fusion for the treatment of 1-level symptomatic cervical disc disease.

            Cervical total disc replacement (TDR) is intended to address radicular pain and preserve functional motion between two vertebral bodies in patients with symptomatic cervical disc disease (SCDD). The purpose of this trial is to compare the safety and efficacy of cervical TDR, ProDisc-C (Synthes Spine Company, L.P., West Chester, PA), to anterior cervical discectomy and fusion (ACDF) surgery for the treatment of one-level SCDD between C3 and C7. The study was conducted at 13 sites. A noninferiority design with a 1:1 randomization was used. Two hundred nine patients were randomized and treated (106 ACDF; 103 ProDisc-C). Visual analog scale (VAS) pain and intensity (neck and arm), VAS satisfaction, neck disability index (NDI), neurological exam, device success, adverse event occurrence, and short form-36 (SF-36) standardized questionnaires. A prospective, randomized, controlled clinical trial was performed. Patients were enrolled and treated in accordance with the US Food and Drug Administration (FDA)-approved protocol. Patients were assessed pre- and postoperatively at six weeks, 3, 6, 12, 18, and 24 months. Demographics were similar between the two patient groups (ProDisc-C: 42.1+/-8.4 years, 44.7% males; Fusion: 43.5 +/- 7.1 years, 46.2% males). The most commonly treated level was C5-C6 (ProDisc-C: 56.3%; Fusion=57.5%). NDI and SF-36 scores were significantly less compared with presurgery scores at all follow-up visits for both the treatment groups (p<.0001). VAS neck pain intensity and frequency as well as VAS arm pain intensity and frequency were statistically lower at all follow-up timepoints compared with preoperative levels (p<.0001) but were not different between treatments. Neurologic success (improvement or maintenance) was achieved at 24 months in 90.9% of ProDisc-C and 88.0% of Fusion patients (p=.638). Results show that at 24 months postoperatively, 84.4% of ProDisc-C patients achieved a more than or equal to 4 degrees of motion or maintained motion relative to preoperative baseline at the operated level. There was a statistically significant difference in the number of secondary surgeries with 8.5% of Fusion patients needing a re-operation, revision, or supplemental fixation within the 24 month postoperative period compared with 1.8% of ProDisc-C patients (p=.033). At 24 months, there was a statistically significant difference in medication usage with 89.9% of ProDisc-C patients not on strong narcotics or muscle relaxants, compared with 81.5% of Fusion patients. The results of this clinical trial demonstrate that ProDisc-C is a safe and effective surgical treatment for patients with disabling cervical radiculopathy because of single-level disease. By all primary and secondary measures evaluated, clinical outcomes after ProDisc-C implantation were either equivalent or superior to those same clinical outcomes after Fusion.
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              Comparison of BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion: clinical and radiographic results of a randomized, controlled, clinical trial.

              A prospective, randomized, multicenter study of surgical treatment of cervical disc disease. To assess the safety and efficacy of cervical disc arthroplasty using a new arthroplasty device at 24-months follow-up. Cervical disc arthroplasty preserves motion in the cervical spine. It is an alternative to fusion after neurologic decompression, whereas anterior decompression and fusion provides a rigorous comparative benchmark of success. We conducted a randomized controlled multicenter clinical trial enrolling patients with cervical disc disease. Ultimately 242 received the investigational device (Bryan Cervical Disc), and 221 patients underwent a single-level anterior cervical discectomy and decompression and fusion as a control group. Patients completed clinical and radiographic follow-up examinations at regular intervals for 2 years after surgery. Analysis of 12- and 24-month postoperative data showed improvement in all clinical outcome measures for both groups; however, 24 months after surgery, the investigational group patients treated with the artificial disc had a statistically greater improvement in the primary outcome variables: Neck disability index score (P = 0.025) and overall success (P = 0.010). With regard to implant- or implant/surgical-procedure-associated serious adverse events, the investigational group had a rate of 1.7% and the control group, 3.2%. There was no statistical difference between the 2 groups with regard to the rate of secondary surgical procedures performed subsequent to the index procedure. Patients who received the artificial cervical disc returned to work nearly 2 weeks earlier than the fusion patients (P = 0.015). Two-year follow-up results indicate that cervical disc arthroplasty is a viable alternative to anterior cervical discectomy and fusion in patients with persistently symptomatic, single-level cervical disc disease.
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                Author and article information

                Journal
                Ther Clin Risk Manag
                Ther Clin Risk Manag
                Therapeutics and Clinical Risk Management
                Therapeutics and Clinical Risk Management
                Dove Medical Press
                1176-6336
                1178-203X
                2019
                28 March 2019
                : 15
                : 531-539
                Affiliations
                [1 ]Department of Anatomy, Institute of Medicine, University of Opole, Opole, Poland, dlatka@ 123456mp.pl
                [2 ]Department of Neurosurgery, University Hospital in Opole, Opole, Poland, dlatka@ 123456mp.pl
                [3 ]Department of Bioengineering, Institute of Biomedical Engineering, Technical University of Wroclaw, Wroclaw, Poland
                Author notes
                Correspondence: Dariusz Latka, Department of Neurosurgery, University Hospital in Opole, Al.Witosa 26, Opole 45-418, Poland, Tel +48 774 552 0724, Fax +48 774 552 0724, Email dlatka@ 123456mp.pl
                Article
                tcrm-15-531
                10.2147/TCRM.S196349
                6445235
                © 2019 Latka et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

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