PRIMA EU Retrospective & Prospective
Research type
Research Study
Full title
A multicentric study evaluating clinical and radiological outcomes of PRIMA humeral stem in total shoulder arthroplasty
IRAS ID
349475
Contact name
Amar Malhas
Contact email
Sponsor organisation
Limacorporate spa
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Total shoulder arthroplasty (TSA) is a surgery to treat severe shoulder joint diseases to relieve pain and restore shoulder function. Conventional artificial shoulder implants often lead to complications especially related to the stem. The PRIMA system consists of a 3D-printed short stem that can be used for both regular and reverse shoulder replacements. This study aims to evaluate the performance and safety of the PRIMA humeral stem over 24 months, looking at clinical outcomes, patient feedback, X-ray results, and the overall durability of the implant.
The study aims to see how patients feel about their shoulder replacements with the PRIMA humeral stem over 24 months. It will also look at X-ray results and check the stability of the implant, evaluate its safety, and see how well the implant lasts over this period.REC name
London - Stanmore Research Ethics Committee
REC reference
25/LO/0433
Date of REC Opinion
28 Jul 2025
REC opinion
Further Information Favourable Opinion