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

CORE-MD undertook systematic reviews of methodologies used in clinical trials to evaluate high-risk medical devices. It compared guidance for clinical trial designs, review statistical methods for device trials, and assess the utility of patient-reported outcomes for regulatory decisions. This dataset was used for the work package 1, task 1.1 of the CORE-MD project and lists the characteristics of the reviewed publications of orthopedic devices.

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 10years before and up to 20years 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) guidelines.

Results: We identified 2912 publications and finally included 151 papers published between 1995 and 2021 (63 on hip stems, 34 on hip cups, 54 on knee systems). We identified no clinical studies published before CE-marking for any selected device, and no studies even up to 20 years after CE-marking in one quarter of devices. There were very few randomized controlled trials, and registry-based studies generally had larger sample sizes and better methodology.

Conclusions: The peer-reviewed literature alone is insufficient as source of clinical investigations of these high-risk devices intended for life-long use. A more systematic, efficient and faster way to evaluating safety and performance is necessary. Using a phased introduction approach, nesting comparative studies of observational and experimental design in existing registries, increasing use of benefit measures, and accelerating surrogate outcomes research, will help to minimise risks and maximise benefits.