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

RecruitingNAAges 20 Years - 60 YearsAllVestre Viken Hospital Trust
NCT06932380 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 patient

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients aged 20-60 years with symptomatic osteochondral lesions of the ankle where conservative treatment or previous surgery has been unsatisfactory. * Patients with a limited cartilage defect that qualifies for Episealer implantation. * Patients who have provided written informed consent to participate in the study. Exclusion Criteria: * Patients with an active infection in the ankle. * Patients with extensive cartilage damage where Episealer is not indicated. * Patients with osteoarthritic changes on the tibial side of the ankle joint. * Patients with severe joint instability. * Patients with severe neurological or systemic diseases. * Patients who smoke. * Patients with substance abuse issues. * Patients unable to attend follow-ups due to distance or other factors.
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What it tests

  • Talus prosthesis
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Where

1 site
Drammen Sykehus
Drammen, Norway
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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