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      Cervical disc arthroplasty (CDA) versus anterior cervical discectomy and fusion (ACDF) in symptomatic cervical degenerative disc diseases (CDDDs): an updated meta-analysis of prospective randomized controlled trials (RCTs)

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          Abstract

          Purpose

          This meta-analysis of randomized controlled trials (RCTs) aims to evaluate the efficacy and safety in cervical disc arthroplasty (CDA) and anterior cervical discectomy and fusion (ACDF) for treating cervical degenerative disc diseases (CDDDs).

          Methods

          The authors searched RCTs in the electronic databases (Cochrane Central Register of Controlled Trials, PubMed, EMBASE, Medline, Embase, Springer Link, Web of Knowledge, OVID and Google Scholar) from their establishment to march 2016 without language restrictions. We also manually searched the reference lists of articles and reviews for possible relevant studies. Researches on CDA versus ACDF in CDDDs were selected in this meta-analysis. The quality of all studies was assessed and effective data was pooled for this meta-analysis. Outcome measurements were surgical parameters (operative time, blood loss, and length of hospital stay), clinical indexes [neck disability index (NDI), neurological success, range of motion (ROM), Visual Analogue Score (VAS)], complications [the number of adverse events, adjacent segment disease (ASD), and reoperation]. Subgroup analysis, sensitivity analysis, and publication bias assessment were also performed, respectively. The meta-analysis was performed with software revman 5.3.

          Results

          37 articles (20 RCTs) with a total 4004 patients (2212 in the CDA and 1792 in the ACDF) met inclusion criteria. Eight types of disc prostheses were used in the included studies. Patients were followed up for at least 2 years in all the studies. No statistically significant differences were found between CDA and ACDF for blood loss [SMD −0.02; 95 % CI (−0.20, 0.17)], length of hospital stay [MD −0.06; 95 % CI (−0.19, 0.06)]. Statistical differences were found between operative time [MD 14.22; 95 % CI (6.73, 21.71)], NDI [SMD −0.27; 95 % CI (−0.43, −0.10)], neurological success [RR 1.13; 95 % CI (1.08, 1.18)], ROM [MD 6.72; 95 % CI (5.72, 7.71)], VAS of neck [SMD −0.40; 95 % CI (−0.75, −0.04)], VAS of arm [SMD −0.55; 95 % CI (−1.04, −0.06)], the rate of adverse events [RR 0.72 95 % CI (0.53, 0.96)], the rate of ASD [RR 0.62; 95 % CI (0.43, 0.88)], and reoperation [RR 0.50; 95 % CI (0.39, 0.63)]. Subgroup analysis stratified by different types of disc prostheses was also performed.

          Conclusions

          CDA is associated with higher clinical indexes and fewer complications than ACDF, indicating that it is a safe and effective treatment for CDDDs. However, the operative time of CDA is longer than ACDF. Because of some limitations, these findings should be interpreted with caution. Additional studies are needed. Large, definitive RCTs are needed.

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          Most cited references49

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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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              Prospective, randomized, multicenter study of cervical arthroplasty: 269 patients from the Kineflex|C artificial disc investigational device exemption study with a minimum 2-year follow-up: clinical article.

              Cervical total disc replacement (CTDR) represents a relatively novel procedure intended to address some of the shortcomings associated with anterior cervical discectomy and fusion (ACDF) by preserving motion at the treated level. This prospective, randomized, multicenter study evaluates the safety and efficacy of a new metal-on-metal CTDR implant (Kineflex|C) by comparing it with ACDF in the treatment of single-level spondylosis with radiculopathy. The study was a prospective, randomized US FDA Investigational Device Exemption (IDE) pivotal trial conducted at 21 centers across the US. The primary clinical outcome measures included the Neck Disability Index (NDI), visual analog scale (VAS) scores, and a composite measure of clinical success. Patients were randomized to CTDR using the Kineflex|C (SpinalMotion, Inc.) cervical artificial disc or ACDF using structural allograft and an anterior plate. A total of 269 patients were enrolled and randomly assigned to either CTDR (136 patients) or to ACDF (133 patients). There were no significant differences between the CTDR and ACDF groups when comparing operative time, blood loss, length of hospital stay, or the reoperation rate at the index level. The overall success rate was significantly greater in the CTDR group (85%) compared with the ACDF group (71%) (p = 0.05). In both groups, the mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the 24-month follow-up (p < 0.0001). Similarly, the VAS pain scores improved significantly by 6 weeks and remained significantly improved through the 24-month follow-up (p < 0.0001). The range of motion (ROM) in the CTDR group decreased at 3 months but was significantly greater than the preoperative mean at 12- and 24-month follow-up. The ROM in the ACDF group was significantly reduced by 3 months and remained so throughout the follow-up. Adjacent-level degeneration was also evaluated in both groups from preoperatively to 2-year follow-up and was classified as none, mild, moderate, or severe. Preoperatively, there were no significant differences between groups when evaluating the different levels of adjacent-level degeneration. At the 2-year follow-up, there were significantly more patients in the ACDF group with severe adjacent-level radiographic changes (p < 0.0001). However, there were no significant differences between groups in adjacent-level reoperation rate (7.6% for the Kineflex|C group and 6.1% for the ACDF group). Cervical total disc replacement allows for neural decompression and clinical results comparable to ACDF. Kineflex|C was associated with a significantly greater overall success rate than fusion while maintaining motion at the index level. Furthermore, there were significantly fewer Kineflex|C patients showing severe adjacent-level radiographic changes at the 2-year follow-up. These results from a prospective, randomized study support that Kineflex|C CTDR is a viable alternative to ACDF in select patients with cervical radiculopathy.
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                Author and article information

                Contributors
                lin_xie2014@163.com
                dorisjiang667@163.com
                295511@qq.com
                317363525@qq.com
                +8618051183772 , shrrng0@gmail.com
                Journal
                Springerplus
                Springerplus
                SpringerPlus
                Springer International Publishing (Cham )
                2193-1801
                27 July 2016
                27 July 2016
                2016
                : 5
                : 1
                : 1188
                Affiliations
                Department of Orthopedic Surgery, Wuhan Orthopedic Hospital, Wuhan Puai Hospital, Huazhong University of Science and Technology, Hanzheng Street 473#, Wuhan, 430033 Hubei Province China
                Article
                2851
                10.1186/s40064-016-2851-8
                4963351
                27516926
                cf806975-cb60-434a-b8e8-3ce22168fb0c
                © The Author(s) 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

                History
                : 17 April 2016
                : 15 July 2016
                Categories
                Review
                Custom metadata
                © The Author(s) 2016

                Uncategorized
                cervical disc arthroplasty (cda),anterior cervical discectomy and fusion (acdf),cervical degenerative disc diseases (cddds),meta-analysis,randomized controlled trials (rcts)

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