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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Osteochondral Defect
• Intervention / Treatment: Device: Episealer Talus implant

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 Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Fredrik Zetterberg; Phone Number: +46 70-839 62 33; Email: fredrik.zetterberg@episurf.com

Study Locations

• Germany
  • Apolda, Germany
    • Recruiting
    • Robert-Koch-Krankenhaus Apolda
    • Contact: Dirk Seifert
  • Hamburg, Germany
    • Recruiting
    • Orthocentrum Hamburg
    • Contact: Johannes Holz
  • Salzgitter, Germany
    • Recruiting
    • St. Elisabeth-Krankenhaus
    • Contact: Qing Shou
  • Sulingen, Germany
    • Recruiting
    • St. Ansgar Sulingen-Bassum
    • Contact: Jens Peters
• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Aleris Hand @ Fot
    • Contact: Jouko Kivioja
  • Stockholm, Sweden
    • Recruiting
    • FotCenter
    • Contact: Hans Wahlström

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Surgery-related information	Retrospective data collection	10 minutes
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Episurf Medical Inc.
• Investigators: Principal Investigator: Jouko Kivioja, Aleris Hand @ Fot

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2023
• Primary Completion (Estimated): March 6, 2024
• Study Completion (Estimated): March 6, 2024

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Actual): January 26, 2024

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Osteochondrosis
• Other Study ID Numbers: Epi_002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No