Autologous Costal Osteochondral Transplantation for Talar Osteochondral Lesions

Study Overview
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Brief Summary
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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.

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

Conditions
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Articular Cartilage Defect

Intervention / Treatment
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* Procedure: Autologous costal osteochondral transplantation
* Procedure: Autologous iliac osteoperiosteal transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. Combined with osteoporosis (T score <-2.5). Other conditions considered inappropriate for participation in this clinical trial by the researchers.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The costa group<br>Autologous costal osteochondral transplantation | Procedure: Autologous costal osteochondral transplantation<br>* Operating steps: Arthroscopic examination of the size and location of the talar osteochondral lesion; 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; Thoroughly remove the talar osteochonral lesion through arthrotomy or Chevron osteotomy of the medial malleolus; Trim the autograft according to the size of the lesion; 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; Suture the joint capsule or reduct and fix the medial malleolus, and close the incision layer by layer.<br>|
| Active Comparator: The ilium group<br>Autologous iliac osteoperiosteal transplantation | Procedure: Autologous iliac osteoperiosteal transplantation<br>* Operating steps: Arthroscopic examination of the size and location of the talar osteochondral lesion; 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. Thoroughly remove the talar osteochonral lesion through arthrotomy or Chevron osteotomy of the medial malleolus; 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; Suture the joint capsule or reduct and fix the medial malleolus, and close the incision layer by layer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score | 0-100 | 24 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score | 0-100 | 3, 6, 12 months after surgery | 
| International Cartilage Repair Society (ICRS) score | 0-12; based on arthroscopic examination | 12 months after surgery | 
| Numeric Rating Scale (NRS) for ankle pain during walking | 0-10 | 3, 6, 12 and 24 months after surgery | 
| Foot and Ankle Ability Measure (FAAM) ADL subscale | 0-100 | 12 and 24 months after surgery | 
| Foot and Ankle Ability Measure (FAAM) Sports subscale | 0-100 | 12 and 24 months after surgery | 
| Tegner score | 0-10 | 12 and 24 months after surgery | 
| Patients' satisfaction degree | 0-10 | 24 months after surgery | 
| Bone union | Based on computed tomography scan | 3 months after surgery or later | 
| Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score | 0-100; based on magnetic resonance imaging | 12 and 24 months after surgery | 
| Numeric Rating Scale (NRS) for donor-site pain | 0-10 | 1, 2, 3, 6, 12 and 24 months after surgery | 
| Any other complications | Any other complications | 1, 2, 3, 6, 12 and 24 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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costa, autologous osteochondral transplantation, autologous osteoperiosteal transplantation, osteochondral lesion of the talus