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NCT06225674
Clinical Investigation on the Outcome of Episealer Talus Post-operation for Treatment of Focal Osteochondral Defects
trial testing Episealer Talus implant in Osteochondral Defect in 25 participants. Status unknown.
6 March 2024
Quick facts
| Lead sponsor | Episurf Medical Inc. |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 25 |
| Start date | 6 November 2023 |
| Primary completion | 6 March 2024 |
| Estimated completion | 6 March 2024 |
| Sites | 6 locations across Sweden, Germany |
Drugs / interventions tested
- Episealer Talus implant
Conditions studied
- Osteochondral Defect — all drugs for Osteochondral Defect →
Sponsor
Episurf Medical Inc.
Who can join
Adults 18 to 99, any sex, with Osteochondral Defect. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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 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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06225674
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other recruiting trials for Osteochondral Defect
Currently open trials in the same condition.
- NCT03908931 — Descriptive Study of the Reconstruction of Osteochondral Lesions of the Knee: Clinical and Imaging Results · NA · recruiting
- NCT04236492 — Study Protocol to Evaluate Clinical and Imaging Results of Knee Fresh Osteochondral Allografts · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06225674 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Episurf Medical Inc.
- Last refreshed: 26 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06225674.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing