Tipmed™ Primary Hip Prosthesis: 24-Month Post-Market Follow-Up in Adults
Official title: A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Primary Hip Prosthesis System
Run by TIPMED Medical Device Manufacturing Ltd. Co. · NCT07651735 · Data updated 2026-11-12
This PMCF study tests the safety and 24‑month performance of the Tipmed hip prosthesis in adults undergoing primary hip replacement.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 101 (estimated) |
| Sponsor | TIPMED Medical Device Manufacturing Ltd. Co. Industry-sponsored |
| Locations | 4 sites (Balıkesir and 3 other locations) |
| Status | Recruiting |
| Started | March 12, 2024 |
| Main results expected | December 31, 2028 |
| Study ends | March 31, 2029 |
| Registry record updated | June 16, 2026 |
| Trial ID | NCT07651735 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 and older undergoing primary hip arthroplasty with the Tipmed™ prosthesis used in the procedure.
✕Probably not a fit
Patients who do not receive any improvement in pain or function, or who experience device-related complications that limit joint performance, may not benefit.
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 multicenter, prospective observational study conducted in Turkey to collect real-world safety and performance data for the Tipmed™ Primary Hip Prosthesis System in adults having primary hip arthroplasty. Enrolling 101 participants across four centers, the study tracks outcomes over 24 months with post-operative visits at 6 weeks, 3, 6, 12, 18, and 24 months. Data collected include Harris Hip Score, adverse events, implant-related complications, radiology, and laboratory markers when available. The aim is to document safety, functionality, and any complications in routine clinical practice. This PMCF will help characterize short- to mid-term performance of the device in a real-world setting.
Why it matters
Potential benefit: If successful, patients may experience improvements in hip function and a clearer understanding of the device’s safety in everyday use.
How similar studies have gone: PMCFs in hip prostheses have previously shown variable safety signals; this study adopts a real-world design to build supplementary evidence for this specific device.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals aged 18 years and older, * Male or female participants, * Subjects who have undergone Primary Hip Arthroplasty (either total or partial) for any indication, * Subjects in whose surgical procedure the Tipmed™ Primary Hip Prosthesis System components were utilized. * Subjects who are not legally restricted (e.g., military personnel, convicts, or individuals under legal guardianship). * Subjects who have voluntarily signed the written Informed Consent Form (ICF). Exclusion Criteria: * Subjects currently participating 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, Balıkesir Provincial Health Directorate, Burhaniye State Hospital
Balıkesir, Turkey (Türkiye) Recruiting -
Dokuz Eylül University Research and Application Hospital
Izmir, Turkey (Türkiye) Recruiting -
Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Izmir Democracy University Buca Seyfi Demirsoy Training and Research Hospital
Izmir, Turkey (Türkiye) 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.