A Talus Implant in Patients Between 20-60 Years of Age Followed up for a Minimum of 2 Years After Surgery

Recruiting now · Not applicable

Conditions studied: Cartilage Lesion

In brief

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.

Key facts

Study ID

NCT06932380

Run by

Vestre Viken Hospital Trust

People needed

10

Starts

2024-10-01

Expected to finish

2030-12-31

Last updated by the study team

2025-04-29

Who can join

Age: 20 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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.

Where it is running

• Drammen Sykehus — Drammen, Norway (enrolling)

Full record on ClinicalTrials.gov

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