Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System
Recruiting · NCT07678034 · Observational (researchers observe without assigning treatment) · Lead sponsor: TIPMED Medical Device Manufacturing Ltd. Co.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
4 locations listed.
- Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City Hospital - Balıkesir, Turkey (Türkiye)
- Republic of Turkey Ministry of Health, Istanbul Provincial Health Directorate, Kanuni Sultan Suleyman Training and Research Hospital - Istanbul, Turkey (Türkiye)
- Republic of Turkey Ministry of Health, Izmir Provincial Health Directorate, Bakircay University Cigli Training and Research Hospital - Izmir, Turkey (Türkiye)
- Dokuz Eylül University Research and Application Hospital - Izmir, Turkey (Türkiye)