Clinical trial Recruiting at 4 sites Observational Ages 18 and up

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.

More Total Hip Arthroplasty (THA) trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment101 (estimated)
SponsorTIPMED Medical Device Manufacturing Ltd. Co.
Industry-sponsored
Locations4 sites (Balıkesir and 3 other locations)
StatusRecruiting
StartedMarch 12, 2024
Main results expectedDecember 31, 2028
Study endsMarch 31, 2029
Registry record updatedJune 16, 2026
Trial IDNCT07651735 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.