NCT06358807 Microfracture With Platelet Rich Plasma Gel Injection for Osteochondral Lesion of the Talus
| NCT ID | NCT06358807 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University Third Hospital |
| Condition | Osteochondral Lesion of Talus |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2025-01-01 |
Trial Parameters
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Brief Summary
The goal of this clinical trial is to learn if combined local injection of platelet rich plasma (PRP) gel adds clinical efficacy to isolated arthroscopic microfracture in treatment of osteochondral lesion of the talus (OLT). The interface integration of the injured area will also be assessed via radiographic follow-up. The main questions it aims to answer are: * Does arthroscopic microfracture combined with PRP gel injection improve ankle function of participants based on American Orthopedic Foot and Ankle Society (AOFAS) Score? * Does arthroscopic microfracture combined with PRP gel injection improve interface integration of the injured cartilage on magnetic resonance imaging (MRI)? Researchers will compare arthroscopic microfracture with concomitant local injection of PRP gel to isolated microfracture to see if intraoperative PRP gel injection adds clinical efficacy to isolated arthroscopic microfracture in treatment of OLT. Participants will: * Undergo either isolated arthroscopic microfracture or microfracture with intraoperative injection of PRP gel * Receive clinical follow-up 3, 6, 12, and 24 months after surgery and answer scales of ankle function assessment * Take MRI preoperatively and 6, 12 and 24 months after surgery
Eligibility Criteria
Inclusion Criteria: * Chronic ankle pain, diagnosed as osteochondral lesion of the talus; * Lesion size ≤ 1.5 cm2 or the diameter of the lesion ≤ 1.5 cm; * 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.