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

NCT06932380 | Recruiting

• 1 other identifier: 24/09300-3
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cartilage Lesion

Keywords

focal cartilage injury; ankle cartilage; patient-specific implant; pilot study

Outcome Measures

Primary Outcomes (1)

• Number of patients undergoing revision surgery

  Revision surgery involves replacing or removing part or all of the talus prosthesis. This may be necessary in the event of various problems with the prosthesis, for example that the prosthesis has loosened from the bone, wear of the prosthesis materials, infection or if the prosthesis dislocates.

  From the time of the index surgery throughout the entire 24-month follow-up period.

Secondary Outcomes (4)

• Patient satisfaction on a scale from 0 to 10

  Baseline - from the time of the index surgery - throughout the entire 24-month follow-up period.

• Patient pain on a scale from 0 to 10

  Baseline - from the time of the index surgery - throughout the entire 24-month follow-up period.

• AOFAS ankle score on a scale from 0 to 100

  Baseline - from the time of the index surgery throughout the entire 24-month follow-up period.

• EQ-5D-5L score

  Baseline - from the time of the index surgery - throughout the entire 24-month follow-up period.

Study Arms (1)

Talus prosthesis

EXPERIMENTAL

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.

Procedure: Talus prosthesis

Interventions

Talus prosthesis PROCEDURE

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.

Talus prosthesis

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Vestre Viken Hospital Trust: lead

Study Sites (1)

Drammen Sykehus

Drammen, 3004, Norway

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This interventional pilot study employs a prospective cohort design to evaluate the safety, feasibility, and efficacy of the patient-specific Episurf Episealer talus implant in treating osteochondral lesions of the ankle. Ten patients aged 20 to 60 years with symptomatic cartilage defects unresponsive to conservative or prior surgical treatment will be included. The intervention consists of open surgical implantation of a custom-made cobalt-chromium implant tailored to each patient's joint anatomy. Outcomes will be assessed through clinical function scores (AOFAS), pain and satisfaction measures (NRS), and health-related quality of life (EQ-5D-5L) over a two-year follow-up period. The study aims to provide preliminary evidence on the implant's clinical performance, with revision rates and complications as primary endpoints.

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 17, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)