A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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).
Locations
Other Locations
Turkey
Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City Hospital
RECRUITING
Balıkesir
Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Burhaniye State Hospital
RECRUITING
Balıkesir
Dokuz Eylül University Research and Application Hospital
RECRUITING
Izmir
Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Izmir Democracy University Buca Seyfi Demirsoy Training and Research Hospital
RECRUITING
Izmir
Contact Information
Primary
Yasemin Onel, Sponsor Rep
yaseminonel@tipmed.com
+90 232 479 33 22
Time Frame
Start Date:2024-03-12
Estimated Completion Date:2029-03-31
Participants
Target number of participants:35
Treatments
Tıpmed™ Revision Hip Prosthesis
A single prospective, multi-center, non-interventional cohort of adult patients tracked during routine clinical practice who have undergone revision hip arthroplasty using the Tıpmed™ Revision Hip Prosthesis System. Patients are enrolled following revision surgery indicated for clinical complications such as aseptic loosening, periprosthetic infection, joint instability, dislocation, or periprosthetic fractures. The cohort captures real-world clinical data based on standard orthopedic indications without any study-mandated modifications to the routine surgical choice.