Evaluating the effectiveness of Episealer Talus for treating ankle cartilage defects
A Retrospective, Observational, Post-market Clinical Investigation on the Outcome of Episealer Talus Post-operation for Treatment of Focal Osteochondral Defects
This study is testing how well the Episealer Talus implant works for adults with ankle cartilage defects and if it helps improve their quality of life after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Episurf Medical Inc. Industry-sponsored |
| Locations | 6 sites (Apolda and 5 other locations) |
| Trial ID | NCT06225674 on ClinicalTrials.gov |
What this trial studies
This observational investigation aims to assess the clinical performance and safety of the Episealer Talus implant in patients with focal osteochondral defects in the ankle. The study will collect retrospective data from approximately 25 adult patients who received the implant at six clinics in Sweden and Germany since January 2020. Information gathered will include patient demographics, surgical details, and post-operative outcomes through questionnaires assessing quality of life. The investigation is expected to last four months, with a focus on understanding the benefits of the implant in treating these defects.
Who should consider this trial
Good fit: Ideal candidates for this investigation are adults aged 18 and older who have previously received the Episealer Talus implant after January 2020.
Not a fit: Patients who have not received the Episealer Talus implant or are under 18 years old will not benefit from this investigation.
Why it matters
Potential benefit: If successful, this investigation could provide valuable insights into the effectiveness of the Episealer Talus implant, potentially improving treatment options for patients with ankle cartilage defects.
How similar studies have performed: While this investigation is focused on a specific implant, similar approaches in evaluating post-operative outcomes for cartilage repair have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed Informed Consent Form * Patients ≥ 18 years old at the time of index procedure * Patients who previously received Episealer Talus implant after January 2020 Exclusion Criteria: * "None"
Where this trial is running
Apolda and 5 other locations
- Robert-Koch-Krankenhaus Apolda — Apolda, Germany (Recruiting)
- OrthoCentrum Hamburg — Hamburg, Germany (Recruiting)
- St. Elisabeth-Krankenhaus — Salzgitter, Germany (Recruiting)
- St. Ansgar Sulingen-Bassum — Sulingen, Germany (Recruiting)
- Aleris Hand @ Fot — Stockholm, Sweden (Recruiting)
- FotCenter — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Jouko Kivioja — Aleris Hand @ Fot
- Study coordinator: Fredrik Zetterberg
- Email: fredrik.zetterberg@episurf.com
- Phone: +46 70-839 62 33
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.