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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Norway
Drammen Sykehus
RECRUITING
Drammen
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 10
Treatments
Experimental: Talus prosthesis
This study consists of a single-arm intervention evaluating the Episurf Episealer talus implant in patients with symptomatic osteochondral lesions of the ankle. All included patients will undergo open surgical implantation of the patient-specific cobalt-chromium implant, designed to restore joint congruency and improve function. Standardized postoperative care, including rehabilitation and follow-up assessments at 6 weeks, 6 months, 1 year, and 2 years, will be provided. Primary outcomes include revision rate and complication incidence, while secondary measures assess pain, functional improvement, and health-related quality of life.
Related Therapeutic Areas
Sponsors
Leads: Vestre Viken Hospital Trust

This content was sourced from clinicaltrials.gov

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