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

NCT07653295 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2026-06-18

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™ 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.

Conditions

  • Revision Hip Arthroplasty
  • Aseptic Loosening of Prosthetic Joint
  • Prostheses-related Infections
  • Joint Instability
  • Periprosthetic Fractures
  • Prosthesis Failure

Interventions

DEVICE

Tıpmed™ Revision Hip Prosthesis System

Post-market evaluation of the commercially available, CE-marked Tıpmed™ Revision Hip Prosthesis System during routine revision orthopedic care. Surgeon-directed device configurations are utilized based on patient-specific bone loss and anatomy, incorporating various mono-block or modular femoral stems, modular femoral body components, and femoral necks. Acetabular reconstruction elements encompass various configurations including acetabular cups, bipolar cups, and titanium metal shells with modular inserts, paired with dedicated bone-anchoring options such as acetabular rings, reinforcement cages, and anatomical rings based on standard clinical routine. In strict adherence to the prospective observational design of this registry, no investigational, experimental, or non-routine surgical interventions are performed.

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 NCT07653295 on ClinicalTrials.gov