An interventional study of Autologous costal osteochondral transplantation and Autologous iliac osteoperiosteal transplantation in Articular Cartilage Defect, sponsored by The Third Affiliated Hospital of Southern Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-09-06.
Sponsored by The Third Affiliated Hospital of Southern Medical University · Not applicable, Interventional, and Treatment
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:
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.
The Third Affiliated Hospital of Southern Medical University is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Autologous costal osteochondral transplantation
Procedure: Autologous costal osteochondral transplantation
Autologous iliac osteoperiosteal transplantation
Procedure: Autologous iliac osteoperiosteal transplantation
Operating 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.
Operating 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.
American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score
0-100
Time frame: 24 months after surgery
American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score
0-100
Time frame: 3, 6, 12 months after surgery
International Cartilage Repair Society (ICRS) score
0-12; based on arthroscopic examination
Time frame: 12 months after surgery
Numeric Rating Scale (NRS) for ankle pain during walking
0-10
Time frame: 3, 6, 12 and 24 months after surgery
Foot and Ankle Ability Measure (FAAM) ADL subscale
0-100
Time frame: 12 and 24 months after surgery
Foot and Ankle Ability Measure (FAAM) Sports subscale
0-100
Time frame: 12 and 24 months after surgery
Tegner score
0-10
Time frame: 12 and 24 months after surgery
Patients' satisfaction degree
0-10
Time frame: 24 months after surgery
Bone union
Based on computed tomography scan
Time frame: 3 months after surgery or later
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score
0-100; based on magnetic resonance imaging
Time frame: 12 and 24 months after surgery
Numeric Rating Scale (NRS) for donor-site pain
0-10
Time frame: 1, 2, 3, 6, 12 and 24 months after surgery
Any other complications
Any other complications
Time frame: 1, 2, 3, 6, 12 and 24 months after surgery
Plan to share: No
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The Third Affiliated Hospital of Southern Medical University