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

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.

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

Global Spine Journal ◽

10.1177/2192568221991105 ◽

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.

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