Early Cases of Single-Level Cervical Total Disc Replacement in Japan-Short-Term Safety Assessment Using Registry Data.

ABSTRACT:

Introduction

Total disc replacement (TDR) using Mobi-C^Ⓡ and Prestige LP^Ⓡ was approved in Japan in 2017. To ensure effective surgical outcomes with TDR, the Japanese TDR guideline was established before its clinical use, and a registry system was developed to monitor the safety of early cases in Japan. This study assessed complications associated with TDR during the early post-approval period using this nationwide registry to evaluate the short-term safety of single-level TDR.

Methods

Data from the nationwide registry covering postoperative 2-year surveillance were analyzed for single-level TDR performed during the post-marketing surveillance period in Japan. The database included patient characteristics, surgical details, complications, and reoperations

SUBMITTER: Utagawa K 

PROVIDER: S-EPMC12521905 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature