Clinical Trial

A Talus Implant in Patients Between 20-60 Years of Age Followed up for a Minimum of 2 Years After Surgery

Recruiting
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Summary
The project will investigate safety, feasibility and efficiency when using Episurf Episeal talus implant in patients with osteochondral ankle injuries. Assessments includes revision rate, complications, pain, function and quality of life over two years. Ten patients (aged 20-60) who have not responded to previous treatment will participate based on informed and written consent. The project uses a prospective cohort design where the patients receive a customized surgical procedure. Data on clinical function, pain and patient satisfaction collected using the AOFAS ankle score, NRS and EQ-5D-5L questionnaire at 6 weeks, 6 months, 1 year and 2 years after the operation. The study can provide valuable insight into the treatment of ankle osteoarthritis, improve the patient's quality of life and function, and represent a step forward in orthopedic surgery, especially for younger, active patients. The results are shared with it the medical community and the general public through publications and presentations.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-16.
Trial Details
NCT Number NCT06932380
Lead Sponsor Vestre Viken Hospital Trust
Conditions Cartilage Lesion
Enrollment 10 participants
Start Date 2024-10-01
Primary Completion 2029-12-31 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-04-29