A Talus Implant in Patients Between 20-60 Years of Age Followed up for a Minimum of 2 Years After Surgery
A Talus Implant in Patients Between 20-60 Years of Age Followed up for a Minimum of 2 Years After Surgery: A Pilot Study
Vestre Viken Hospital Trust
10 participants
Oct 1, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria8
- 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.
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Interventions
The Episealer Talus is an individualised resurfacing implant intended for use on either the medial or lateral talus. It aims to treat patients suffering from pain and reduced mobility due to focal osteochondral lesions in the talus.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06932380