Using a custom talus implant for ankle cartilage injuries in patients aged 20-60
A Talus Implant in Patients Between 20-60 Years of Age Followed up for a Minimum of 2 Years After Surgery: A Pilot Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Sponsor | Vestre Viken Hospital Trust Academic / other |
| Locations | 1 site (Drammen) |
| Trial ID | NCT06932380 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with extensive cartilage damage, active infections, or severe joint instability may not benefit from this study.
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 performed: While this approach is innovative, similar studies using patient-specific implants have shown promise in other joints, suggesting potential for success in this application.
Eligibility criteria
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 this trial is running
Drammen
- Drammen Sykehus — Drammen, Norway (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.