Actively Recruiting
Evaluation of the Effectiveness and Safety of Autologous Costal Osteochondral Transplantation in the Treatment of Talar Osteochondral Lesions: a Randomized Controlled Clinical Trial
Led by The Third Affiliated Hospital of Southern Medical University · Updated on 2023-09-06
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of autologous costal osteochondral transplantation compared with autologous osteoperiosteal transplantation in treating Hepple Stage V talar osteochondral lesions. The main goal is to determine if the costal osteochondral transplantation can provide better clinical outcomes and improved cartilage repair with fewer donor site complications than the osteoperiosteal transplantation. Participants will be randomly assigned to one of these two surgical treatments. The study involves two treatment groups: one receiving the autologous costal osteochondral transplantation, which includes harvesting an osteochondral column from the rib and implanting it into the talar defect, and the other receiving autologous iliac osteoperiosteal transplantation, which involves obtaining a cylindrical osteoperiosteal column from the iliac crest for implantation. Both surgeries include removing the talar lesion, filling the cavity with cancellous bone, and ensuring the transplant surface aligns with the surrounding cartilage. After surgery, all participants will follow the same rehabilitation and follow-up plan. Participants will be monitored over time with various assessments including the American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale at multiple intervals up to 24 months after surgery. Additional measures include pain ratings during walking, cartilage repair evaluations by MRI, functional scores, bone healing, patient satisfaction, and monitoring for any complications. The study aims to collect detailed data on clinical outcomes and safety over two years following the surgical treatment.
CONDITIONS
Brief Title
Autologous Costal Osteochondral Transplantation for Talar Osteochondral Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic Hepple stage V talar osteochondral lesions with a lesion depth 5 mm and an AOFAS score 580 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and initial recovery period
Participants undergo surgery to receive either autologous costal osteochondral transplantation or autologous iliac osteoperiosteal transplantation to repair talar osteochondral lesions, followed by immediate post-operative care.
1 surgery visit plus immediate post-operative care visits
Duration - Up to 24 months after surgery
Participants are monitored after surgery to assess recovery, bone union, pain levels, joint function, cartilage repair, and any complications.
Multiple visits at 1, 2, 3, 6, 12, and 24 months after surgery
Trial Site Locations
Total: 1 location
1
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510630
Actively Recruiting
Research Team
H
Hao Guo, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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