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

NCT07651735 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 101

Last updated 2026-06-16

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • TIPMED Medical Device Manufacturing Ltd. Co.

    lead INDUSTRY

Principal Investigators

  • Ahmet Karakaşlı, Professor · Dokuz Eylul University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-12
Primary Completion
2028-12-31
Completion
2029-03-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07651735 on ClinicalTrials.gov