Using a custom talus implant for ankle cartilage injuries in patients aged 20-60
Official title: A Talus Implant in Patients Between 20-60 Years of Age Followed up for a Minimum of 2 Years After Surgery: A Pilot Study
Run by Vestre Viken Hospital Trust · NCT06932380 · Data updated 2026-11-12
This study is testing a custom metal implant to see if it can help people aged 20-60 with ankle cartilage injuries feel better after other treatments haven't worked.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 60 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Vestre Viken Hospital Trust Academic / other |
| Locations | 1 site (Drammen) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2030 |
| Registry record updated | April 29, 2025 |
| Trial ID | NCT06932380 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 20-60 with symptomatic osteochondral lesions of the ankle who have not found relief from conservative treatments or previous surgeries.
✕Probably not a fit
Patients with extensive cartilage damage, active infections, or severe joint instability may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project investigates the safety, feasibility, and effectiveness of the Episurf Episeal talus implant in patients with osteochondral ankle injuries who have not responded to previous treatments. The study involves a prospective cohort design where ten patients aged 20-60 will undergo a customized surgical procedure to replace damaged cartilage with a patient-specific metal implant. Assessments will be conducted over two years, measuring clinical function, pain, and patient satisfaction using various questionnaires at multiple follow-up points. The goal is to provide insights into improving treatment for ankle osteoarthritis and enhancing patients' quality of life and function.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain relief and joint function for patients with localized cartilage defects in the ankle.
How similar studies have gone: While this approach is innovative, similar studies using patient-specific implants have shown promise in other joints, suggesting potential for success in this application.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Drammen Sykehus
Drammen, Norway Recruiting
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.