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Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System

Recruitingn/aAges 18 Years - anyAllTIPMED Medical Device Manufacturing Ltd. Co.
NCT07653295 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Tıpmed™ Revision Hip Prosthesis System
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Where

4 sites
Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City Hospital
Balıkesir, Turkey (Türkiye)
Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Burhaniye State Hospital
Balıkesir, Turkey (Türkiye)
Dokuz Eylül University Research and Application Hospital
Izmir, Turkey (Türkiye)
Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Izmir Democracy University Buca Seyfi Demirsoy Training and Research Hospital
Izmir, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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