Status:
RECRUITING
A Talus Implant in Patients Between 20-60 Years of Age Followed up for a Minimum of 2 Years After Surgery
Lead Sponsor:
Vestre Viken Hospital Trust
Conditions:
Cartilage Lesion
Eligibility:
All Genders
20-60 years
Phase:
NA
Brief 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, complication...
Detailed Description
Localized cartilage injuries in the ankle occur when distinct areas of the cartilage in the ankle joint become damaged or worn down. This can lead to pain, swelling, reduced mobility and function, and...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06932380
Start Date
October 1 2024
End Date
December 31 2030
Last Update
April 29 2025
Active Locations (1)
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1
Drammen Sykehus
Drammen, Norway, 3004