Status:
RECRUITING
Autologous Osteoperiosteal Transplantation for the Treatment of Severe Osteochondral Lesions of the Talus
Lead Sponsor:
Peking University Third Hospital
Conditions:
Osteochondral Lesion of Talus
Autologous Osteoperiosteal Transplantation
Eligibility:
All Genders
18-60 years
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 osteoperi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06527482
Start Date
September 1 2023
End Date
September 1 2026
Last Update
August 6 2024
Active Locations (1)
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1
Peking University Third Hospital
Beijing, China