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Recruiting
NCT07653295
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System
Conditions: Revision Hip Arthroplasty, Aseptic Loosening of Prosthetic Joint, Prostheses-related Infections, Joint Instability, Periprosthetic Fractures, Prosthesis Failure
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 35
Sponsor: TIPMED Medical Device Manufacturing Ltd. Co.
Location: Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City Hospital Balıkesir
Summary
This is a multicenter, prospective, observational, post-market clinical follow-up (PMCF) study designed to evaluate the safety and clinical performance of the Tipmed™ Revision Hip Prosthesis System in adult participants undergoing revision hip arthroplasty. The study aims to gather real-world clinical evidence on the 24-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 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.
Source: ClinicalTrials.gov (NCT07653295). StuddyBuddy aggregates publicly available trial information.