Autologous Osteoperiosteal Transplantation for the Treatment of Severe Osteochondral Lesions of the Talus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Autologous Osteoperiosteal Transplantation.
- Who it may be relevant to
- Registry conditions: Osteochondral Lesion of Talus, Autologous Osteoperiosteal Transplantation. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter Prospective Cohort Study of Autologous Osteoperiosteal Transplantation for the Treatment of Severe Osteochondral Lesions of the Talus
Overview
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
Interventions
- Procedure Autologous Osteoperiosteal Transplantation
After 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
Primary outcome measures
- Foot and Ankle Outcome Score (FAOS) [Time frame: Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery]
Secondary outcome measures (6)
- American Orthopedic Foot and Ankle Society Score (AOFAS) [Time frame: Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery]
- Visual Analogue Scale (VAS) [Time frame: Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery]
- Ankle Activity Score (AAS) [Time frame: Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery]
- Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) [Time frame: 12 and 24 months after surgery]
- International Cartilage Repair Society (ICRS) [Time frame: 12 months after surgery]
- Complications [Time frame: Final follow-up (48 months after surgery)]
Eligibility criteria
Inclusion criteria
- 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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Peking University Third Hospital — Beijing
Identifiers
NCT: NCT06527482 · M2023418