Clinical Trial

Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System

Recruiting
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Summary
This study is designed as a prospective, multicenter, observational post-market clinical follow-up (PMCF) study to evaluate the safety and effectiveness of the Tipmed™ Shoulder Prosthesis System at 12 months postoperatively. The study population includes adult patients who undergo reverse shoulder arthroplasty (RSA) or shoulder hemiarthroplasty (HA) using the Tipmed™ implant systems due to various clinical indications such as osteoarthritis, rotator cuff arthropathy, or proximal humerus fractures. The main objective is to gather real-world clinical evidence on the 12-month post-operative safety profile, potential complications, and functional outcomes of the device during routine clinical practice.
Trial Details
NCT Number NCT07678034
Lead Sponsor TIPMED Medical Device Manufacturing Ltd. Co.
Conditions Glenohumeral Osteoarthritis, Proximal Humerus Fracture, Rotator Cuff Arthropathy, Rheumatoid Arthritis, Avascular Necrosis
Enrollment 54 participants
Start Date 2025-06-16
Primary Completion 2030-03-15 (estimated)
Study Completion 2030-06-15 (estimated)
Updated on ClinicalTrials.gov 2026-07-01