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

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.

Eligibility

Inclusion Criteria:

* Individuals aged 18 years and older,
* Male or female participants,
* Participants who have undergone Reverse Shoulder Arthroplasty or Shoulder Hemiarthroplasty for any valid indication,
* Participants in whose surgical procedure the Tipmed™ Shoulder Prosthesis System product configurations were utilized.
* Participants who are not legally restricted (e.g., military personnel, convicts, or individuals under legal guardianship).
* Participants who have voluntarily signed the written Informed Consent Form (ICF).

Exclusion Criteria:

* Concurrent participation in any other interventional clinical trial.

Conditions6

Browse More Trials