Actively Recruiting
A Talus Implant in Patients Between 20-60 Years of Age Followed up for a Minimum of 2 Years After Surgery
Led by Vestre Viken Hospital Trust · Updated on 2025-04-29
10
Participants Needed
1
Research Sites
326 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 patients. The results are shared with it the medical community and the general public through publications and presentations.
CONDITIONS
Official 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 ankle lesions unresponsive to conservative treatment or prior surgery
- Patients with a limited cartilage defect suitable for Episealer implantation
- Patients who have provided written informed consent to participate
You will not qualify if you...
- Patients with an active infection in the ankle
- Patients with extensive cartilage damage where Episealer is not suitable
- 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
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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