RESUMO
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) guidelines. Results: We identified 2912 publications and finally included 151 papers published between 1995 and 2021 (63 on hip stems, 34 on hip cups, and 54 on knee systems). We identified no clinical studies published before Conformité Européene (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. Conclusion: The peer-reviewed literature alone is insufficient as a source of clinical investigations of these high-risk devices intended for life-long use. A more systematic, efficient, and faster way to evaluate safety and performance is necessary. Using a phased introduction approach, nesting comparative studies of observational and experimental design in existing registries, increasing the use of benefit measures, and accelerating surrogate outcomes research will help to minimize risks and maximize benefits.
RESUMO
Background and purpose - Revision total hip arthroplasty (THA) is associated with higher dislocation rates than primary THA. We compared the risk of dislocation within 6 months and all-cause re-revision during the whole study period using either the dual-mobility cup or the unipolar cup. Methods - We used a prospective hospital registry-based cohort including all total and cup-only revision THAs performed between 2003 and 2013. The cups used were either dual-mobility or unipolar; the choice was made according to the preference of the surgeon. 316 revision THAs were included. The mean age of the cohort was 69 (25-98) years and 160 THAs (51%) were performed in women. The dual-mobility group (group 1) included 150 THAs (48%) and the mean length of follow-up was 31 (0-128) months. The unipolar group (group 2) included 166 THAs (53%) and the mean length of follow-up was 52 (0-136) months. Results - The incidence of dislocation within 6 months was significantly lower with the dual-mobility cup than with the unipolar cup (2.7% vs. 7.8%). The unadjusted risk ratio (RR) was 0.34 (95% CI: 0.11-1.02) and the adjusted RR was 0.28 (95% CI: 0.09-0.87). The number of patients needed to treat with a dual-mobility cup in order to prevent 1 case of dislocation was 19. The unadjusted incidence rate ratio for all-cause re-revision in the dual-mobility group compared to the unipolar group was 0.6 (95% CI: 0.3-1.4). Interpretation - Use of a dual-mobility rather than a unipolar cup in revision THA reduced the risk of dislocation within 6 months.
