Tipmed Shoulder Prosthesis PMCF: safety and outcomes after shoulder replacement
Official title: A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System
Run by TIPMED Medical Device Manufacturing Ltd. Co. · NCT07678034 · Data updated 2026-11-12
This PMCF study tests the safety and function of the Tipmed shoulder prosthesis in adults undergoing reverse shoulder or hemiarthroplasty in real-world practice.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 54 (estimated) |
| Sponsor | TIPMED Medical Device Manufacturing Ltd. Co. Industry-sponsored |
| Locations | 4 sites (Balıkesir and 3 other locations) |
| Status | Recruiting |
| Started | June 16, 2025 |
| Main results expected | March 15, 2030 |
| Study ends | June 15, 2030 |
| Registry record updated | July 1, 2026 |
| Trial ID | NCT07678034 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older undergoing RSA or HA with the Tipmed prosthesis for conditions like osteoarthritis, rotator cuff arthropathy, or proximal humerus fracture.
✕Probably not a fit
Patients who do not experience improvements in function or who experience complications may not benefit from the device in this study context.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multicenter, observational post-market follow-up study to collect real-world safety and effectiveness data for the Tipmed Shoulder Prosthesis System at 12 months after surgery. Patients receiving either reverse shoulder arthroplasty or shoulder hemiarthroplasty with Tipmed implants are followed through standard care visits at 6 weeks, 3 months, 6 months, and 12 months. Outcomes include the Modified Constant-Murley Score for function and the SF-12 for quality of life, along with continuous safety reporting of AEs, SAEs, and device-specific complications. Data are analyzed separately for RSA and HA cohorts to understand any differences in performance. The study follows MDR 2017/745 requirements and uses retrospective preoperative data where available, with no extra procedures beyond routine clinical practice.
Why it matters
Potential benefit: If successful, the study could support broader use of the Tipmed prosthesis by confirming its safety and how well it restores function in real-world settings.
How similar studies have gone: Other PMCF or registry studies of shoulder prostheses have demonstrated valuable safety and performance data in routine practice; this study follows that established approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City Hospital
Balıkesir, Turkey (Türkiye) Recruiting -
Republic of Turkey Ministry of Health, Istanbul Provincial Health Directorate, Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Turkey (Türkiye) Not yet recruiting -
Republic of Turkey Ministry of Health, Izmir Provincial Health Directorate, Bakircay University Cigli Training and Research Hospital
Izmir, Turkey (Türkiye) Not yet recruiting -
Dokuz Eylül University Research and Application Hospital
Izmir, Turkey (Türkiye) Not yet recruiting
Study contacts
- Study coordinator: Yasemin Önel, Sponsor Rep
- Email: yaseminonel@tipmed.com
- Phone: +90 232 479 33 22
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.