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| ID | Type | Description | Link |
|---|---|---|---|
| YL202203 | Other Grant/Funding Number | The Dean's Fund |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The costa group | Experimental | Autologous costal osteochondral transplantation |
|
| The ilium group | Active Comparator | Autologous iliac osteoperiosteal transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous costal osteochondral transplantation | Procedure | Operating steps:
|
| Measure | Description | Time Frame |
|---|---|---|
| American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score | 0-100 | 24 months after surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao Guo, MD | Contact | +8617612003968 | 416363977@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Canjun Zeng, PhD | The Third Affiliated Hospital of Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affiliated Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510630 | China |
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|
| Autologous iliac osteoperiosteal transplantation | Procedure | Operating steps:
|
|
| 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 |