Autologous Osteoperiosteal Transplantation for the Treatment of Severe Osteochondral Lesions of the Talus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorPeking University Third Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial population
Severe OLT patients undergoing autologous osteoperiosteal transplantation that meet the above criteria
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Autologous Osteoperiosteal Transplantation
Procedure/SurgeryAfter full exposure of the lesion, the center of the cystic lesion was determined and drilled perpendicularly using a 2-mm pin. Then, a 4.5-mm cannulated bore was used to drill the lesion until the cyst was reached, and a small bone socket was created. A harvester tube matching the diameter of the cyst was used to enlarge the bone socket with care to avoid damage to the adjacent normal cartilage. The cystic lesion was debrided thoroughly, and the sclerotic wall of the cyst was freshened using a curette. The harvester tube with a matched diameter was driven in to a depth of 15 to 20 mm at the 2-cm proximal part of the anterior superior iliac spine perpendicularly without violation of the lateral wall of the crest. When necessary, small pieces of cancellous bone were also harvested from the iliac crest using a bone curette then grafted into the peripheral area of the cyst to fill up the remaining space of the cyst around the bone socket in the talus.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgerySecondary outcomes
1
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.
Time frame
Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery2
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.
Time frame
Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery3
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.
Time frame
Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery4
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.
Time frame
12 and 24 months after surgerySponsors and contacts
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Source ClinicalTrials.gov