Observational Study to Monitor Safety and Function of Tipmed21 Shoulder Prosthesis System After Reverse Shoulder Arthroplasty or Hemiarthroplasty in Adults

What this Trial Is About

Researchers are conducting a prospective, multicenter observational study to evaluate the safety and effectiveness of the Tipmed21 Shoulder Prosthesis System in adults who have undergone reverse shoulder arthroplasty or shoulder hemiarthroplasty. The study focuses on real-world clinical outcomes at 12 months after surgery for conditions such as osteoarthritis, rotator cuff arthropathy, and proximal humerus fractures. The goal is to gather data on safety, complications, and functional results in routine clinical practice. The study follows two groups of patients one with reverse shoulder arthroplasty using various Tipmed21 components, and another with shoulder hemiarthroplasty involving isolated humeral head replacement. Since participants are enrolled after surgery, the study does not involve new surgical interventions but observes the outcomes of the implanted devices. Data is collected retrospectively from medical charts and prospectively during follow-up visits scheduled at 6 weeks, 3 months, 6 months, and 12 months postoperatively. Participants will undergo assessments including functional performance measured by the Modified Constant-Murley Score and quality of life evaluated through the Short Form-12 questionnaire. Safety is monitored by tracking all adverse events, serious adverse events, and device-related complications such as loosening, infection, dislocation, and scapular notch formation over 12 months. Statistical analyses will compare results between the two treatment groups, with total participation lasting up to one year after surgery.

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