Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Talus Implant in Patients Between 20-60 Years of Age Followed up for a Minimum of 2 Years After Surgery
Sponsor: Vestre Viken Hospital Trust
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.
Official title: A Talus Implant in Patients Between 20-60 Years of Age Followed up for a Minimum of 2 Years After Surgery: A Pilot Study
Key Details
Gender
All
Age Range
20 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2024-10-01
Completion Date
2030-12-31
Last Updated
2025-04-29
Healthy Volunteers
No
Conditions
Interventions
Talus prosthesis
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)
Drammen Sykehus
Drammen, Norway