Autologous Osteoperiosteal Transplantation for the Treatment of Severe Osteochondral Lesions of the Talus
Recruiting now
Conditions studied: Osteochondral Lesion of Talus, Autologous Osteoperiosteal Transplantation
In brief
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
Key facts
- Study ID
- NCT06527482
- Run by
- Peking University Third Hospital
- People needed
- 60
- Starts
- 2023-09-01
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2024-08-06
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Peking University Third Hospital — Beijing, China (enrolling)
Full record on ClinicalTrials.gov
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