RecruitingNot ApplicableNCT06932380

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


Sponsor

Vestre Viken Hospital Trust

Enrollment

10 participants

Start Date

Oct 1, 2024

Study Type

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

Min Age: 20 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Talus prosthesis for people with cartilage lesion. The study is currently recruiting participants at 1 location. People eligible for this study include aged 20 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETalus 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

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NCT06932380


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