NCT07653295 Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System
| NCT ID | NCT07653295 |
| Status | Recruiting |
| Phase | — |
| Sponsor | TIPMED Medical Device Manufacturing Ltd. Co. |
| Condition | Revision Hip Arthroplasty |
| Study Type | OBSERVATIONAL |
| Enrollment | 35 participants |
| Start Date | 2024-03-12 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 35 participants in total. It began in 2024-03-12 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Ahmet Karakaşlı, Professor
STUDY DIRECTOR
Dokuz Eylul University
Frequently Asked Questions
Who can join the NCT07653295 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Revision Hip Arthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07653295 currently recruiting?
Yes, NCT07653295 is actively recruiting participants. Contact the research team at yaseminonel@tipmed.com for enrollment information.
Where is the NCT07653295 trial being conducted?
This trial is being conducted at Balıkesir, Turkey (Türkiye), Balıkesir, Turkey (Türkiye), Izmir, Turkey (Türkiye), Izmir, Turkey (Türkiye).
Who is sponsoring the NCT07653295 clinical trial?
NCT07653295 is sponsored by TIPMED Medical Device Manufacturing Ltd. Co.. The principal investigator is Ahmet Karakaşlı, Professor at Dokuz Eylul University. The trial plans to enroll 35 participants.