Clinical trial NCT06225674: Clinical Investigation on the Outcome of Episealer Talus Post-operation for Treatment of Focal Osteochondral Defects
Official title: A Retrospective, Observational, Post-market Clinical Investigation on the Outcome of Episealer Talus Post-operation for Treatment of Focal Osteochondral Defects
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteochondral Defect
Lead sponsor: Episurf Medical Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

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.

Eligibility 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"

Primary outcomes:
measure: Assessment of total SEFAS (self-reported foot and ankle score) outcome
timeFrame: 1 hour
Secondary outcomes:
measure: Assessment of total FAOS (Foot and Ankle Outcome Score) and subscale (pain, other symptoms, activities of daily living, sport and recreational function,
timeFrame: 30 minutes
measure: Assessment of total Visual Analogue Scale and subsections (rest, walking running, climb steps)
timeFrame: 10 minutes
measure: Surgery-related information
timeFrame: 10 minutes
measure: Additional clinical performance parameters of Episealer Talus implant
timeFrame: 10 minutes
Other outcomes:
measure: The retrospective investigation design includes a non-systematic assessment of the spontaneous reporting of AEs, ADEs, SAEs, SADEs, and DDs.
timeFrame: 1 hour
Locations:
city: Apolda
country: Germany
facility: Robert-Koch-Krankenhaus Apolda
city: Hamburg
country: Germany
facility: OrthoCentrum Hamburg
city: Salzgitter
country: Germany
facility: St. Elisabeth-Krankenhaus
city: Sulingen
country: Germany
facility: St. Ansgar Sulingen-Bassum
city: Stockholm
country: Sweden
facility: Aleris Hand @ Fot
city: Stockholm
country: Sweden
facility: FotCenter
Study officials:
affiliation: Aleris Hand @ Fot
name: Jouko Kivioja
role: PRINCIPAL_INVESTIGATOR
References: