Autologous Costal Osteochondral Transplantation for Talar Osteochondral Lesions
- Conditions
- Articular Cartilage Defect
- Interventions
- Procedure: Autologous costal osteochondral transplantationProcedure: Autologous iliac osteoperiosteal transplantation
- Registration Number
- NCT05942430
- Lead Sponsor
- The Third Affiliated Hospital of Southern Medical University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description The costa group Autologous costal osteochondral transplantation Autologous costal osteochondral transplantation The ilium group Autologous iliac osteoperiosteal transplantation Autologous iliac osteoperiosteal transplantation
- Primary Outcome Measures
Name Time Method American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score 24 months after surgery 0-100
- Secondary Outcome Measures
Name Time Method Numeric Rating Scale (NRS) for ankle pain during walking 3, 6, 12 and 24 months after surgery 0-10
International Cartilage Repair Society (ICRS) score 12 months after surgery 0-12; based on arthroscopic examination
Tegner score 12 and 24 months after surgery 0-10
American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score 3, 6, 12 months after surgery 0-100
Foot and Ankle Ability Measure (FAAM) Sports subscale 12 and 24 months after surgery 0-100
Bone union 3 months after surgery or later Based on computed tomography scan
Any other complications 1, 2, 3, 6, 12 and 24 months after surgery Any other complications
Foot and Ankle Ability Measure (FAAM) ADL subscale 12 and 24 months after surgery 0-100
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score 12 and 24 months after surgery 0-100; based on magnetic resonance imaging
Patients' satisfaction degree 24 months after surgery 0-10
Numeric Rating Scale (NRS) for donor-site pain 1, 2, 3, 6, 12 and 24 months after surgery 0-10
Trial Locations
- Locations (1)
The Third Affiliated Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China