NCT07678034Recruiting
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System
A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 54 (estimated)
- First submitted
- 24 Jun 2026
- Start date
- 16 Jun 2025
- Primary completion date
- 15 Mar 2030
- Lead sponsor
- TIPMED Medical Device Manufacturing Ltd. Co.
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT07678034
What you commit to
- Study type: Observational
- Planned participants: 54
- From 16 Jun 2025 to the primary completion date, 15 Mar 2030
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in any other interventional clinical trial.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City Hospital Coordinator of this site? Confirm its status | Balıkesir | Turkey (Türkiye) | Recruiting |
| Republic of Turkey Ministry of Health, Istanbul Provincial Health Directorate, Kanuni Sultan Suleyman Training and Research Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Not yet recruiting |
| Republic of Turkey Ministry of Health, Izmir Provincial Health Directorate, Bakircay University Cigli Training and Research Hospital Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Not yet recruiting |
| Dokuz Eylül University Research and Application Hospital Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.