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

Osteochondral Defect Clinical Trial

Official title:

A Retrospective, Observational, Post-market Clinical Investigation on the Outcome of Episealer Talus Post-operation for Treatment of Focal Osteochondral Defects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06225674
• Other study ID #: Epi_002
• Status: Recruiting
• Start date: November 6, 2023
• Est. completion date: March 6, 2024

Study information

• Verified date: January 2024
• Source: Episurf Medical Inc.
• Contact: Fredrik Zetterberg
• Phone: +46 70-839 62 33
• Email: fredrik.zetterberg[@]episurf.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 6, 2024
• Est. primary completion date: March 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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"

Related Conditions & MeSH terms

• Osteochondral Defect

Intervention

Device:
• Episealer Talus implant
This is an observational study, no intervention will be done. 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.

Locations

Country	Name	City	State
Germany	Robert-Koch-Krankenhaus Apolda	Apolda
Germany	OrthoCentrum Hamburg	Hamburg
Germany	St. Elisabeth-Krankenhaus	Salzgitter
Germany	St. Ansgar Sulingen-Bassum	Sulingen
Sweden	Aleris Hand @ Fot	Stockholm
Sweden	FotCenter	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Episurf Medical Inc.

Countries where clinical trial is conducted

Germany,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The retrospective investigation design includes a non-systematic assessment of the spontaneous reporting of AEs, ADEs, SAEs, SADEs, and DDs.	All safety variables, deriving from the non-systematic assessment, will be tabulated for the Safety Population: AE, ADE, SAE, SADE, and DD.	1 hour
Primary	Assessment of total SEFAS (self-reported foot and ankle score) outcome	SEFAS data will be extracted from the patient´s reported outcome (PROs). Range 0-48, low score is better	1 hour
Secondary	Assessment of total FAOS (Foot and Ankle Outcome Score) and subscale (pain, other symptoms, activities of daily living, sport and recreational function,	FAOS data will be extracted from the patient´s reported outcome (PROs). Range 0-100, low score is better	30 minutes
Secondary	Assessment of total Visual Analogue Scale and subsections (rest, walking running, climb steps)	VAS data will be extracted from the patient´s reported outcome (PROs), Range 0-10, low score is better.	10 minutes
Secondary	Surgery-related information	Retrospective data collection	10 minutes
Secondary	Additional clinical performance parameters of Episealer Talus implant	Subject's and PI's treatment satisfaction (Self reported, scale 1-5 low score is better)	10 minutes