TSA Registry - V6
Research type
Research Study
Full title
Total Shoulder Arthroplasty Multi-Center Registry
IRAS ID
339250
Contact name
Michael Walton
Contact email
Sponsor organisation
Arthrex, GmbH
Clinicaltrials.gov Identifier
Duration of Study in the UK
15 years, 0 months, 0 days
Research summary
This multicenter, prospective registry study is being carried out to evaluate the long-term performance and safety of Arthrex shoulder prosthesis systems by collecting real-world data. Patients between 18 and 100 years of age who decided to undergo a standard-of-care primary or revision shoulder arthroplasty procedure with an Arthrex shoulder prosthesis will be approached for enrollment in the study. Patients will be included after ICF signature if all inclusion and exclusion criteria are met. Baseline data will be collected preoperatively and the patients will be followed for up to 10 years focusing on the patient's clinical, radiographic, and safety outcomes. Patient visits at the clinic (including radiographs and range of motion/strength measurement) follow standard-of-care (6 and 12 weeks and 1,2,5,7 and 10 years post-op). In addition patients will be asked to complete questionnaires regarding their shoulder pain, functionality and general quality of life at 9 and 26 weeks, 1,2,3,4,5,6,7,8,9 and 10 years post-op to provide a comprehensive assessment of patient well-being. Device related adverse events will be collected throughout the study.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
25/WM/0066
Date of REC Opinion
15 May 2025
REC opinion
Further Information Favourable Opinion