A Talus Implant in Patients Between 20-60 Years of Age Followed up for a Minimum of 2 Years After… (NCT06932380) | Clinical Trial Compass
RecruitingNot Applicable
A Talus Implant in Patients Between 20-60 Years of Age Followed up for a Minimum of 2 Years After Surgery
Norway10 participantsStarted 2024-10-01
Plain-language 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, 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.
Who can participate
Age range
20 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients undergoing revision surgery
Timeframe: From the time of the index surgery throughout the entire 24-month follow-up period.