International Study on Safety and Performance of the PERFORM Humeral System for Shoulder Arthroplasty with 10-Year Follow-Up

What this Trial Is About

This research aims to collect safety and performance data on the PERFORM20 Humeral System, a device used for partial or total shoulder replacement in patients with conditions such as osteoarthritis, avascular necrosis, post-traumatic arthrosis of the shoulder region, and rotator cuff tear arthropathy. It is an international, single-arm, multicenter, prospective post-market clinical follow-up study designed to evaluate patient outcomes over time. The study focuses on patient-reported measures related to quality of life, pain, and function, as well as safety and radiographic assessments. Participants will undergo shoulder arthroplasty using the Tornier Perform Humeral Stem device. Data will be collected at baseline, during surgery, immediately after surgery, and then annually for up to 10 years post-operation. The study monitors the devices safety and performance through various assessments including patient satisfaction and radiological imaging throughout the follow-up period. During the study, participants will be assessed using patient-reported outcome measures such as ASES, Constant Murley, SANE, Subject Satisfaction, and EQ-5D scores from baseline through follow-up visits up to 10 years. Researchers will also track adverse events, revision surgeries, and imaging evaluations of the shoulder. The study involves long-term monitoring to understand the safety and effectiveness of the implant over time.

Perform Humeral System Study