Autologous Osteoperiosteal Transplantation for the Treatment of Severe Osteochondral Lesions of the Talus
NCT Number: NCT06527482
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Osteochondral Lesion of Talus|Autologous Osteoperiosteal Transplantation
Interventions: PROCEDURE: Autologous Osteoperiosteal Transplantation
Sponsor: Peking University Third Hospital
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-01
Completion Date: 2026-09-01
Locations: Peking University Third Hospital, Beijing, China

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

Primary Outcome Measures: Foot and Ankle Outcome Score (FAOS), The Foot and Ankle Outcome Score (FAOS) is an extensive tool designed to evaluate the patient's perception of their foot and ankle conditions, with 0 indicating the worst possible outcome, and 100 representing the best possible outcome. The scale of FAOS score will be answered by participants during clinic follow-up preoperatively, and 6 weeks 3, 6, 12 and 24 months after surgery., Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery
Secondary Outcome Measures: American Orthopedic Foot and Ankle Society Score (AOFAS), The AOFAS is a standardized tool used to evaluate the outcomes of treatments for foot and ankle disorders, with 0 indicating severe disability or extreme problems, and 100 indicating no disability or problems.The scale of AOFAS score will be answered by participants during clinic follow-up preoperatively, and 6 weeks 3, 6, 12 and 24 months after surgery., Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery|Visual Analogue Scale (VAS), The Visual Analog Scale (VAS) is a simple and widely used method for assessing the intensity of pain and other subjective experiences, with 0 indicating no pain, and 100 indicating the worst possible pain. The scale of VAS score will be answered by participants during clinic follow-up preoperatively, and 6 weeks 3, 6, 12 and 24 months after surgery., Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery|Ankle Activity Score (AAS), The AAS is a scoring tool to assess sports activity for the ankle joint, with zero point indicating the lowest activity level, and ten points indicating the highest activity level. The scale of AAS score will be answered by participants during clinic follow-up preoperatively, and 6 weeks 3, 6, 12 and 24 months after surgery., Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery|Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART), The Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score is a grading system used to evaluate the quality of cartilage repair tissue through MRI (Magnetic Resonance Imaging), with 0 indicating poor cartilage repair quality, and 100 indicating excellent cartilage repair quality. MOCART score will be assessed on magnetic resonance imaging 12 and 24 months after surgery., 12 and 24 months after surgery|International Cartilage Repair Society (ICRS), The International Cartilage Repair Society (ICRS) score is a grading system used to assess the condition of articular cartilage, especially in the context of cartilage repair procedures, with 0 indicating poor cartilage repair quality, and 12 indicating excellent cartilage repair quality. ICRS score will be assessed 12 months, 12 months after surgery|Complications, Complications, including infection,hematoma, stiffness, recurrent ankle pain will be continuously followed during clinic follow-up and will be overall collected 24 months after surgery., Final follow-up (48 months after surgery)