Clinical investigations to evaluate high-risk orthopaedic devices: a systematic review of the peer-reviewed medical literature.

ABSTRACT:

Purpose

The objective of this systematic review was to give an overview of clinical investigations regarding hip and knee arthroplasty implants published in peer-reviewed scientific medical journals before entry into force of the EU Medical Device Regulation in May 2021.

Methods

We systematically reviewed the medical literature for a random selection of hip and knee implants to identify all peer-reviewed clinical investigations published within 10 years before and up to 20 years after regulatory approval. We report study characteristics, methodologies, outcomes, measures to prevent bias, and timing of clinical investigations of 30 current implants. The review process was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) gu

SUBMITTER: Lubbeke A 

PROVIDER: S-EPMC10646516 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature