scholarly journals Adverse Events Following Cervical Disc Arthroplasty: A Systematic Review

2017 ◽  
Vol 8 (2) ◽  
pp. 178-189 ◽  
Author(s):  
Jordan C. Xu ◽  
Chandni Goel ◽  
Michael F. Shriver ◽  
Joseph E. Tanenbaum ◽  
Michael P. Steinmetz ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Industry Funding ◽  
Quality Of Reporting ◽  
Cervical Arthroplasty ◽  
Disc Arthroplasty ◽  
Vascular Compromise

Study Design: Systematic review. Objectives: Cervical arthroplasty is an increasingly popular treatment of cervical radiculopathy and myelopathy. An understanding of the potential adverse events (AEs) is important to help both clinicians and patients. We sought to provide a comprehensive systematic review of the AEs reported in all randomized controlled trials (RCTs) of cervical disc arthroplasty in an attempt to characterize the quality of reporting. Methods: We conducted a systematic review of MEDLINE and Web of Science for RCTs of cervical disc arthroplasty reporting AEs. We reported the most frequently mentioned AEs, including dysphagia/dysphonia, vascular compromise, dural injury, and infections. We recorded the presence of industry funding and scored the quality of collection methods and reporting of AEs. Results: Of the 3734 identified articles, 29 articles met full inclusion criteria. The quality of AE reporting varied significantly between studies, and a combined meta-analysis was not feasible. The 29 articles covered separate 19 RCTs. Eight studies were US Food and Drug Administration (FDA) investigational device exemption (IDE) trials. Rates were recorded for the following AEs: dysphagia/dysphonia (range = 1.3% to 27.2%), vascular compromise (range = 1.1% to 2.4%), cervical wound infection (range = 1.2% to 22.5%), and cerebrospinal fluid leak (range = 0.8% to 7.1%). Conclusions: There is a lack of consistency in reporting of AEs among RCTs of cervical arthroplasty. FDA IDE trials scored better in AE event reporting compared to other studies. Standardized definitions for AEs and standardized data collection methodology are needed to improve future studies.

A systematic review of randomized trials on the effect of cervical disc arthroplasty on reducing adjacent-level degeneration

2010 ◽  
Vol 28 (6) ◽  
pp. E5 ◽  
Author(s):  
Ricardo Vieira Botelho ◽  
Osmar José dos Santos Moraes ◽  
Gustavo Alberto Fernandes ◽  
Yuri dos Santos Buscariolli ◽  
Wanderley Marques Bernardo
Keyword(s):  
Systematic Review ◽  
Statistical Significance ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Adjacent Segment ◽  
Number Needed To Treat ◽  
Adjacent Level ◽  
Cervical Arthroplasty ◽  
Disc Arthroplasty ◽  
Adjacent Level Degeneration

Object Anterior cervical discectomy and fusion had been considered a safe and effective procedure for radiculopathy and myelopathy in the cervical spine, but degeneration in adjacent spinal levels has been a problem in some patients after fusion. Since 2002, cervical disc arthroplasty has been established as an alternative to fusion. The objective of this study was to review data concerning the role of cervical arthroplasty in reducing adjacent-level degeneration. Methods A systematic review was performed using the MEDLINE, EMBASE, Cochrane, and LILACS databases, focusing on a structured question involving the population of interest, types of intervention, types of control, and outcomes studied. Results No study has specifically compared the results of arthroplasty with the results of fusion with respect to the rate of postoperative development of adjacent-segment degenerative disease. One paper described a rate for adjacent-level surgery. The level of evidence of that paper was classified 2b, and although its authors found a statistically significant between-groups difference (arthroplasty vs fusion) using log-rank analysis, re-analysis according to number needed to treat (in the current paper) did not reveal statistical significance. Conclusions Adjacent-level degeneration has not been adequately studied in a review of the available randomized controlled trials on this topic, and there is no clinical evidence of reduction in adjacent-level degeneration with the use of cervical arthroplasty.

scholarly journals Quality of Life Following Prestige LP Cervical Disc Arthroplasty in a Prospective Multicountry Study

10.14444/6030 ◽  
2019 ◽  
Vol 13 (3) ◽  
pp. 221-229
Author(s):  
JAN STULIK ◽  
MARTON RONAI ◽  
BRUNO RUDINSKY ◽  
DANIEL ZARZYCKI ◽  
DARIUSZ LATKA ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Disc Arthroplasty

Postoperative MRI Visualization of the Cervical Spine Following Cervical Disc Arthroplasty: A Prospective Single-Center Comparison of a Titanium and Cobalt-Chromium Prosthesis

2021 ◽  
pp. 219256822199110
Author(s):  
Vadim A. Byvaltsev ◽  
Andrei A. Kalinin ◽  
Marat A. Aliyev ◽  
K. Daniel Riew
Keyword(s):  
Observer Agreement ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Single Center ◽  
Cobalt Chromium ◽  
Significant Deterioration ◽  
Disc Arthroplasty ◽  
Jarvik 2000 ◽  
Total Arthroplasty

Study Design: Prospective non-randomized single-center cohort study. Objectives: To analyze the quality of postoperative magnetic resonance imaging of 2 structurally different cervical disc arthroplasty devices at the index and adjacent levels. Methods: A non-randomized, comparative, prospective, single-center study included 40 patients (23 men and 17 women) aged 32 (26-40) years. Two study groups were utilized: in the first (n = 20), a titanium prosthesis was used; in the second (n = 20), a cobalt-chromium implant was used. Evaluation of MRI studies before and after surgery was performed using sagittal and axial T2 weighted images by 2 specialists who were blinded to the prosthesis that was used. To determine the quality of an MRI image, the classification of Jarvik 2000, the radiological and orthopedic scales for assessing artifacts were used. Results: There was good-to-excellent inter-observer agreement for all of the MR parameters used for the titanium and satisfactory-to-good for the cobalt chromium group. The analysis of the quality of postoperative imaging using the Jarvik 2000 scale showed a statistically significant deterioration in MR images in the cobalt chromium group ( P < 0.001), compared to the titanium ( P = 0.091). Following a single-level total arthroplasty, the titanium group had better MRI images according to radiological and orthopedic scales ( P < 0.001). Conclusion: Titanium cervical disc arthroplasty devices result in superior postoperative MR imaging, as compared to cobalt chromium prostheses, as the latter significantly reduces image quality due to the pronounced ferromagnetic effect.

Ten-Year Outcomes of 1- and 2-Level Cervical Disc Arthroplasty From the Mobi-C Investigational Device Exemption Clinical Trial

Neurosurgery ◽  
2020 ◽  
Author(s):  
Kee Kim ◽  
Greg Hoffman ◽  
Hyun Bae ◽  
Andy Redmond ◽  
Michael Hisey ◽  
...  
Keyword(s):  
Neck Disability Index ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Adjacent Segment ◽  
Disc Disease ◽  
Cervical Arthroplasty ◽  
Disc Arthroplasty ◽  
Arm Pain ◽  
Pain Outcomes ◽  
Neck Disability

Abstract BACKGROUND Short- and mid-term studies have shown the effectiveness of cervical disc arthroplasty (CDA) to treat cervical disc degeneration. OBJECTIVE To report the 10-yr outcomes of a multicenter experience with cervical arthroplasty for 1- and 2-level pathology. METHODS This was a prospective study of patients treated with CDA at 1 or 2 contiguous levels using the Mobi-C® Cervical Disc (Zimmer Biomet). Following completion of the 7-yr Food and Drug Administration postapproval study, follow-up continued to 10 yr for consenting patients at 9 high-enrolling centers. Clinical and radiographic endpoints were collected out to 10 yr. RESULTS At 10 yr, patients continued to have significant improvement over baseline Neck Disability Index (NDI), neck and arm pain, neurologic function, and segmental range of motion (ROM). NDI and pain outcomes at 10 yr were significantly improved from 7 yr. Segmental and global ROM and sagittal alignment also were maintained from 7 to 10 yr. Clinically relevant adjacent segment pathology was not significantly different between 7 and 10 yr. The incidence of motion restricting heterotopic ossification at 10 yr was not significantly different from 7 yr for 1-level (30.7% vs 29.6%) or 2-level (41.7% vs 39.2%) patients. Only 2 subsequent surgeries were reported after 7 yr. CONCLUSION Our results through 10 yr were comparable to 7-yr outcomes, demonstrating that CDA with Mobi-C continues to be a safe and effective surgical treatment for patients with 1- or 2-level cervical degenerative disc disease.

scholarly journals Multilevel cervical arthroplasty: current evidence. A systematic review

2017 ◽  
Vol 42 (2) ◽  
pp. E4 ◽  
Author(s):  
Andrei F. Joaquim ◽  
K. Daniel Riew
Keyword(s):  
Systematic Review ◽  
Clinical Studies ◽  
Case Reports ◽  
Current Evidence ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Cervical Arthroplasty ◽  
Study Objective ◽  
Single Level ◽  
Cervical Surgery

OBJECTIVE Cervical disc arthroplasty (CDA) has been demonstrated to be an effective treatment modality for single-level cervical radiculopathy or myelopathy. Its advantages over an anterior cervical discectomy and fusion (ACDF) include motion preservation and decreased reoperations at the index and adjacent segments up to 7 years postoperatively. Considering the fact that many patients have multilevel cervical disc degeneration (CDD), the authors performed a systematic review of the clinical studies evaluating patients who underwent multilevel CDA (2 or more levels). METHODS A systematic review in the MEDLINE database was performed. Clinical studies including patients who had multilevel CDA were selected and included. Case reports and literature reviews were excluded. Articles were then grouped according to their main study objective: 1) studies comparing multilevel CDA versus ACDF; 2) studies comparing single-level CDA versus multilevel CDA; and 3) multilevel CDA after a previous cervical spine surgery. RESULTS Fourteen articles met all inclusion criteria. The general conclusions were that multilevel CDA was at least as safe and effective as ACDF, with preservation of cervical motion when compared with ACDF and potentially with fewer reoperations expected in most of the studies. Multilevel CDAs are clinically effective as single-level surgeries, with good clinical and radiological outcomes. Some studies reported a higher incidence of heterotopic ossification in multilevel CDA when compared with single-level procedures, but without clinical relevance during the follow-up period. A CDA may be indicated even after a previous cervical surgery in selected cases. CONCLUSIONS The current literature supports the use of multilevel CDA. Caution is necessary regarding the more restrictive indications for CDA when compared with ACDF. Further prospective, controlled, multicenter, and randomized studies not sponsored by the device manufactures are desirable to prove the superiority of CDA surgery over ACDF as the treatment of choice for CDD in selected cases.

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