NCT07678034 Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System
| NCT ID | NCT07678034 |
| Status | Recruiting |
| Phase | — |
| Sponsor | TIPMED Medical Device Manufacturing Ltd. Co. |
| Condition | Glenohumeral Osteoarthritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 54 participants |
| Start Date | 2025-06-16 |
| Primary Completion | 2030-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 54 participants in total. It began in 2025-06-16 with a primary completion date of 2030-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Özgün Karakuş, Assoc. Prof.
STUDY DIRECTOR
Republic of Turkey Ministry of Health Balıkesir Provincial Health Directorate, Atatürk City Hospital
Frequently Asked Questions
Who can join the NCT07678034 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glenohumeral Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07678034 currently recruiting?
Yes, NCT07678034 is actively recruiting participants. Contact the research team at yaseminonel@tipmed.com for enrollment information.
Where is the NCT07678034 trial being conducted?
This trial is being conducted at Balıkesir, Turkey (Türkiye), Istanbul, Turkey (Türkiye), Izmir, Turkey (Türkiye), Izmir, Turkey (Türkiye).
Who is sponsoring the NCT07678034 clinical trial?
NCT07678034 is sponsored by TIPMED Medical Device Manufacturing Ltd. Co.. The principal investigator is Özgün Karakuş, Assoc. Prof. at Republic of Turkey Ministry of Health Balıkesir Provincial Health Directorate, Atatürk City Hospital. The trial plans to enroll 54 participants.