NCT06527482 Autologous Osteoperiosteal Transplantation for the Treatment of Severe Osteochondral Lesions of the Talus
| NCT ID | NCT06527482 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University Third Hospital |
| Condition | Osteochondral Lesion of Talus |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2026-01-01 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The goal of this clinical trial is to establish a multicenter prospective cohort of patients with severe osteochondral lesion of the talus (OLT), evaluate the clinical efficacy of autologous osteoperiosteal transplantation and the incidence of postoperative donor-site morbidity. The main questions it aims to answer are: Does autologous osteoperiosteal transplantation have good clinical outcomes in the treatment of severe OLT? Does autologous osteoperiosteal transplantation treat severe OLT with fewer postoperative complications? Participants will: Undergo autologous osteoperiosteal transplantation for OLT Receive clinical follow-up 3, 6, 12, and 24 months after surgery and answer scales of ankle function assessment Take CT and MRI preoperatively and 12 and 24 months after surgery
Eligibility Criteria
Inclusion Criteria: * Chronic ankle pain, diagnosed as Osteochondral Lesions of the Talus (OLT); * Hepple V OLT on the medial side of the talus or the diameter of the lesion ≥ 8 mm; * Conservative treatment of at least 3 months fails to relieve symptoms; * Willingness to voluntarily participate in the trial and to sign informed consent. Exclusion Criteria: * Varus or valgus deformity of the ankle of more than 5 degrees; * Grade III injury of the lateral collateral ligament of ankle; * Chronic synovitis (rheumatoid arthritis, pigmented villous nodular synovitis, etc.); * Joint fibrosis, stiffness, and significantly restricted range of motion; * Evidence of moderate to severe knee osteoarthritis on plain radiographs; * Failure to complete the rehabilitation protocol as required; * Patient medically not fit for surgery, radiographs or MRI; * For women, pregnant, planning to be pregnant or lactating.