NCT05942430

Autologous Costal Osteochondral Transplantation for Talar Osteochondral Lesions

Evaluation of the Effectiveness and Safety of Autologous Costal Osteochondral Transplantation in the Treatment of Talar Osteochondral Lesions: a Randomized Controlled Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: The Third Affiliated Hospital of Southern Medical University · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Articular Cartilage Defect

Interventions

Type	Name	Description
PROCEDURE	Autologous costal osteochondral 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.
PROCEDURE	Autologous iliac osteoperiosteal transplantation	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.

Timeline

• Start date: 2023-09-01
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2023-07-12
• Last updated: 2023-09-06

Locations

1 site across 1 country: China