RecruitingNCT07651735

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

A Multicenter, Prospective, Observational, 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.

Enrollment

101 participants

Start Date

Mar 12, 2024

Study Type

OBSERVATIONAL

Conditions

Osteoarthritis (OA) of the hip Total Hip Arthroplasty (THA)Joint Diseases Femoral Neck Fractures Hemiarthroplasty

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Tipmed™ Primary Hip Prosthesis System for people with femoral neck fractures, hemiarthroplasty, and other related conditions. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETipmed™ 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)

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NCT07651735