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

NCT06225674 | Unknown

• 1 other identifier: Epi_002
• Study Type: observational
• Target: 25
• Locations: 2 countries
• Sites: 6

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).

Conditions

Osteochondral Defect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Assessment of total FAOS (Foot and Ankle Outcome Score) and subscale (pain, other symptoms, activities of daily living, sport and recreational function,

  30 minutes

• Assessment of total Visual Analogue Scale and subsections (rest, walking running, climb steps)

  10 minutes

• Surgery-related information

  10 minutes

• Additional clinical performance parameters of Episealer Talus implant

  10 minutes

Other Outcomes (1)

• The retrospective investigation design includes a non-systematic assessment of the spontaneous reporting of AEs, ADEs, SAEs, SADEs, and DDs.

  1 hour

Interventions

Episealer Talus implant DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Signed Informed Consent Form
• Patients ≥ 18 years old at the time of index procedure
• Patients who previously received Episealer Talus implant after January 2020

You may not qualify if:

• "None"

Sponsors & Collaborators

• Episurf Medical Inc.: lead

Study Sites (6)

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 Officials

• Jouko Kivioja

  Aleris Hand @ Fot

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fredrik Zetterberg

CONTACT

+46 70-839 62 33; fredrik.zetterberg@episurf.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 26, 2024
• Study Start: November 6, 2023
• Primary Completion: March 6, 2024
• Study Completion: March 6, 2024
• Last Updated: January 26, 2024

Record last verified: 2024-01

Locations

SE (2); DE (4)