About this trial
The goal of this clinical trial is to evaluate the effectiveness and safety of autologous costal osteochondral transplantation in the treatment of Hepple Stage V talar osteochondral lesions, compared with autologous osteoperiosteal transplantation. The main question it aims to answer is:
• Whether autologous costal osteochondral transplantation can achieve better clinical outcomes and cartilage repair quality with lower donor site morbidity than autologous osteoperiosteal transplantation in the treatment of Hepple Stage V talar osteochondral lesions.
Participants will be randomly assigned to the intervention group (undergoing autologous costal osteochondral transplantation) or the control group (undergoing autologous osteoperiosteal transplantation). Both groups of participants will receive the same postoperative rehabilitation process and follow-up evaluation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Symptomatic Hepple stage V talar osteochondral lesions with a lesion depth ≥5 mm and an AOFAS score ≤80 points;
Failed conservative treatment for at least 6 months;
Unilateral talar osteochondral lesions without corresponding lesions on the tibial side;
Willingness to participate in this clinical trial and signing an informed consent form.
Disqualifiers
Combined with lower limb deformity.
Combined with hip or knee joint diseases.
Combined with ipsilateral ankle arthritis with joint space narrowing .
Diagnosis of gouty arthritis of the ankle joint.
Trial design
Parallel
Treatments tested in this trial
Autologous costal osteochondral transplantation
Procedure/SurgeryOperating steps: 1. Arthroscopic examination of the size and location of the talar osteochondral lesion; 2. Make a transverse incision (approximately 4 cm long) at the osteochondral junction of the fifth or sixth rib, and harvest an osteochondral column from the rib; 3. Thoroughly remove the talar osteochonral lesion through arthrotomy or Chevron osteotomy of the medial malleolus; 4. Trim the autograft according to the size of the lesion; 5. Fill the peri-lesion cavity with cancellous bone, and finally embed the costal osteochondral autograft into the talar defect, ensuring that the cartilage surface of the transplant to be flush with the normal talar cartilage around it; 6. Suture the joint capsule or reduct and fix the medial malleolus, and close the incision layer by layer.
Autologous iliac osteoperiosteal transplantation
Procedure/SurgeryOperating steps: 1. Arthroscopic examination of the size and location of the talar osteochondral lesion; 2. Make an incision along the anterior iliac crest. At the time of exposure, pay attention not to damage the periosteum. Obtain a cylindrical osteoperiosteal column by an appropriate-sized harvester tube. 3. Thoroughly remove the talar osteochonral lesion through arthrotomy or Chevron osteotomy of the medial malleolus; 4. Fill the peri-lesion cavity with cancellous bone, and finally embed the iliac osteoperiosteal autograft into the talar defect, ensuring that the periosteum surface of the transplant to be flush with the normal talar cartilage around it; 5. Suture the joint capsule or reduct and fix the medial malleolus, and close the incision layer by layer.
Treatment groups
Trial outcomes
Primary outcomes
American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score
0-100
Secondary outcomes
American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score
0-100
International Cartilage Repair Society (ICRS) score
0-12; based on arthroscopic examination
Numeric Rating Scale (NRS) for ankle pain during walking
0-10
Foot and Ankle Ability Measure (FAAM) ADL subscale
0-100
Sponsors and contacts
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