Actively Recruiting
A Talus Implant in Patients Between 20-60 Years of Age Followed up for a Minimum of 2 Years After Surgery: A Pilot Study
Led by Vestre Viken Hospital Trust · Updated on 2025-04-29
10
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, feasibility, and effectiveness of the Episurf Episeal talus implant in patients aged 20 to 60 years with symptomatic osteochondral lesions of the ankle. These cartilage injuries cause pain, swelling, and limited mobility, often leading to osteoarthritis. Conventional treatments may not fully heal the damage, especially in younger active patients, so this study explores a customized implant designed to restore joint function and improve quality of life over two years. The study involves a single group of ten patients receiving an open surgical procedure to implant a patient-specific cobalt-chromium talus prosthesis. This implant is tailored using advanced imaging and 3D modeling to match each patient's ankle anatomy and damaged cartilage area. After surgery, patients will follow a standardized rehabilitation program with follow-up visits at 6 weeks, 6 months, 1 year, and 2 years to monitor recovery, complications, pain, and function. Participants will undergo clinical exams, X-rays, and MRI scans before surgery to assess their injury. Researchers will collect data on pain levels, ankle function using the AOFAS score, patient satisfaction, and quality of life with the EQ-5D-5L questionnaire throughout the two-year follow-up. The main outcome is the number of patients needing revision surgery. Safety and complications will also be recorded to understand the implant’s long-term impact on ankle cartilage injuries.
CONDITIONS
Brief Title
A Talus Implant in Patients Between 20-60 Years of Age Followed up for a Minimum of 2 Years After Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 1 day
Participants undergo open surgical implantation of a patient-specific talus implant made of cobalt-chromium to replace the damaged cartilage and bone in the ankle.
1 surgical visit (in-person)
Duration - 2 years
Participants receive standardized postoperative care including rehabilitation and physiotherapy, with clinical follow-up visits to assess safety, function, and pain relief.
Follow-up visits at 6 weeks, 6 months, 1 year, and 2 years postoperatively
Trial Site Locations
Total: 1 location
1
Drammen Sykehus
Drammen, Norway, 3004
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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