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Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Primary Hip Prosthesis System
Sponsor: TIPMED Medical Device Manufacturing Ltd. Co.
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.
Official title: A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Primary Hip Prosthesis System
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
101
Start Date
2024-03-12
Completion Date
2029-03-31
Last Updated
2026-06-16
Healthy Volunteers
No
Conditions
Interventions
Tipmed™ Primary Hip Prosthesis System
Post-market utilization of the commercially available Tipmed™ Primary Hip Prosthesis System during routine orthopedic care. Device components include various configurations such as cemented or uncemented stems (anatomic or square cross-section), acetabular cups, bipolar cups, and titanium metal shells fitted according to standard clinical routine and patient anatomy. No investigational or non-routine interventions are performed as part of this observational registry.
Locations (4)
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)