Clinical Investigation on the Outcome of Episealer Talus Post-operation for Treatment of Focal Osteochondral Defects

Recruiting

• Conditions: Osteochondral Defect

• Registration Number: NCT06225674
• Lead Sponsor: Episurf Medical Inc.

Brief Summary

This is a retrospective, observational, single-arm, multi-centre, post-market clinical investigation designed to verify clinical performance and safety of Episealer Talus post-operation for treatment of focal osteochondral defects on the talus bone in the ankle. This retrospective investigation aims to collect data from patients with focal osteochondral defects treated with Episealer Talus, to provide insight on the potential benefit of Episealer Talus in the treatment of focal osteochondral defects.

The aim for the clinical investigation is to collect data from approximately 25 adult subjects who were treated for focal osteochondral defect with Episealer Talus implant in 6 clinics (Sweden and Germany) since January 2020, when the devices were CE-marked. The data collected for each subject will include demographics and data generated in relation to the surgery itself and the post-surgery phases including e.g. focal defect grade and position, collected through medical record review. Each subject will also be asked to complete a set of QoL questionnaires (SEFAS, FAOS and VAS).

Detailed Description

This is a retrospective, observational, single-arm, multi-centre, post-market clinical investigation designed to verify clinical performance and safety of Episealer Talus post-operation for treatment of focal OCDs. The overall clinical investigation is based on the patient's reported outcome (PROs) from OCD patients previously treated with Episealer Talus implant after January 2020. In total approximately 25 adult subjects, male or female, from 6 clinics (Sweden and Germany) will be included in the investigation.

Subjects will be identified by the investigational site team through medical record review and/or site knowing the subjects from performing the implantation after January 2020. Following collection of the subject´s signed informed consent, subject demographics, health- and surgery-related data will be collected from the subjects' medical records. Therefore, only one visit is planned for each subject during the clinical investigation. The performance variables relate to quality of life, and all subjects will be asked to fill in three questionnaires (SEFAS, FAOS and VAS).

The overall duration of the investigation is estimated to be 4 months, including a 1 month recruitment period. Each subject is estimated to spend approximately 1-2 hour for completing the informed consent and completing the questionnaires. Subject´s participation in the clinical investigation will be terminated once the questionnaires have been completed and the site team considers all data collected for the subject.

Study Timeline

• Study Start: 2023-11-06
• Study First Submitted: 2023-12-13
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-25
• Last Update Submitted: 2024-01-25
• Study First Posted: 2024-01-26
• Last Update Posted: 2024-01-26
• Primary Completion: 2024-03-06
• Study Completion: 2024-03-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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"

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of total SEFAS (self-reported foot and ankle score) outcome	1 hour	SEFAS data will be extracted from the patient´s reported outcome (PROs). Range 0-48, low score is better

Secondary Outcome Measures

Name	Time	Method
Surgery-related information	10 minutes	Retrospective data collection
Assessment of total FAOS (Foot and Ankle Outcome Score) and subscale (pain, other symptoms, activities of daily living, sport and recreational function,	30 minutes	FAOS data will be extracted from the patient´s reported outcome (PROs). Range 0-100, low score is better
Additional clinical performance parameters of Episealer Talus implant	10 minutes	Subject's and PI's treatment satisfaction (Self reported, scale 1-5 low score is better)
Assessment of total Visual Analogue Scale and subsections (rest, walking running, climb steps)	10 minutes	VAS data will be extracted from the patient´s reported outcome (PROs), Range 0-10, low score is better.

Trial Locations

Locations (6)

OrthoCentrum Hamburg; 🇩🇪 Hamburg, Germany

Robert-Koch-Krankenhaus Apolda; 🇩🇪 Apolda, Germany

St. Elisabeth-Krankenhaus; 🇩🇪 Salzgitter, Germany

FotCenter; 🇸🇪 Stockholm, Sweden

Aleris Hand @ Fot; 🇸🇪 Stockholm, Sweden

St. Ansgar Sulingen-Bassum; 🇩🇪 Sulingen, Germany