Clinical Trial

Clinical Outcome After Episealer Talus Implant in Treatment of Osteochondral Lesion of the Talus

Active, Not Recruiting
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Summary
Autologous Chondrocyte Implantation (ACI) is an appealing technique whereby cartilage is harvested from the joint in a first operation. This biopsy is processed, individual cells are freed and cultivated and, in a second procedure, injected into the defect that has been covered by a periosteal graft). A second generation includes a matrix (MACI) into which the cells are injected/cultivated. Recently, collagen membranes are used to cover the cells or cover a micro-fractured defect. Good results have been reported although return to previous sports remains a challenge . Long term results are lacking. More important is the fact that these treatments are directed towards restoring the articular cartilage whereas the patient's symptoms are generated by the bone and not the cartilage. Treatment of an OCD with a small metallic implant has been tested in recent years. Results have been promising by some reports, while a high revision rates was reported by others. A recent 2-8 years follow-up study revealed a survival rate of 95 %
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-07-22; most recent amendment 2025-07-29.
Trial Details
NCT Number NCT06522139
Lead Sponsor Stefano Zaffagnini
Conditions Osteochondral Defect
Enrollment 20 participants
Start Date 2021-10-14
Primary Completion 2023-09-12 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2025-08-01