Tipmed Revision Hip Prosthesis: 24-Month Post-Market Follow-Up
Official title: A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System
Run by TIPMED Medical Device Manufacturing Ltd. Co. · NCT07653295 · Data updated 2026-11-12
This PMCF study tests the safety and how well the Tipmed Revision Hip Prosthesis works in adults undergoing hip revision surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 35 (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 18, 2026 |
| Trial ID | NCT07653295 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) undergoing revision hip arthroplasty with the Tipmed Revision Hip Prosthesis System used in the procedure.
✕Probably not a fit
Patients with non-revision hip procedures or those not receiving the Tipmed Revision Hip Prosthesis in the revision surgery.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, prospective observational study collects real-world data on the Tipmed Revision Hip Prosthesis System in adults undergoing revision hip arthroplasty. Participants are followed for 24 months after surgery with visits at 6 weeks, 3, 6, 12, 18, and 24 months, during which safety events and functional outcomes are recorded. The Harris Hip Score is used to quantify joint function, and adverse events, implant-related complications, and re-revisions are tracked. Data are gathered from medical records and study visits to assess short- to mid-term safety and performance in routine clinical practice in Turkey. The study plans to enroll 35 eligible participants across multiple centers.
Why it matters
Potential benefit: If successful, the study could provide real-world evidence on the safety and functional performance of the Tipmed Revision Hip Prosthesis, informing clinicians and patients about expected outcomes after revision surgery.
How similar studies have gone: PMCF and post-market follow-up studies in orthopedic implants have demonstrated the value of real-world safety and performance data, though results are device-specific and context-dependent.
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 Revision Hip Arthroplasty (either total revision or partial component revision) for any indication (such as a documented joint failure or prosthesis-related clinical complication), * Participants in whose revision procedure the Tıpmed™ Revision Hip Prosthesis System components 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: * 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 Onel, 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.