A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Primary 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™ Primary Hip Prosthesis System in adult subjects undergoing primary 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,
• 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).
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 Önel, 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:101
Treatments
Tipmed™ Primary Hip Prosthesis
A single prospective cohort of adult patients tracked during routine clinical practice who have undergone primary hip arthroplasty (either total hip arthroplasty or partial hemiarthroplasty) using the Tipmed™ Primary Hip Prosthesis System (including cemented or uncemented stem options based on standard surgical indications).