Actively Recruiting
A Multicenter Prospective Cohort Study of Autologous Osteoperiosteal Transplantation for the Treatment of Severe Osteochondral Lesions of the Talus
Led by Peking University Third Hospital · Updated on 2024-08-06
60
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter prospective cohort study to evaluate the clinical results and safety of autologous osteoperiosteal transplantation in patients with severe osteochondral lesions of the talus (OLT). The study aims to determine whether this procedure provides good clinical outcomes and fewer postoperative complications when treating severe OLT. This study is sponsored by Peking University Third Hospital. Participants will undergo autologous osteoperiosteal transplantation, where a bone graft is taken from the iliac crest and transplanted to repair the lesion in the talus. The surgical procedure involves drilling and debriding the cystic lesion before grafting bone tissue. The study includes clinical follow-up visits at 3, 6, 12, and 24 months after surgery, with imaging examinations such as CT and MRI performed before surgery and at 12 and 24 months post-operation. During the study, participants will complete ankle function assessments including the Foot and Ankle Outcome Score (FAOS) at multiple time points up to 24 months after surgery. Additional measures include the American Orthopedic Foot and Ankle Society Score, Visual Analogue Scale for pain, Ankle Activity Score, and cartilage repair imaging assessments. Complications will be monitored up to 48 months after surgery to evaluate safety and donor-site morbidity. Participants will be closely followed to assess recovery and clinical outcomes over this period.
CONDITIONS
Brief Title
Autologous Osteoperiosteal Transplantation for the Treatment of Severe Osteochondral Lesions of the Talus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 60 years
- Chronic ankle pain diagnosed as osteochondral lesions of the talus (OLT)
- Hepple V OLT on the medial side of the talus or lesion diameter 6 8 mm
- Symptoms not relieved after at least 3 months of conservative treatment
- Willingness to participate voluntarily and sign informed consent
You will not qualify if you...
- Varus or valgus ankle deformity greater than 5 degrees
- Grade III injury of the lateral collateral ligament of the ankle
- Chronic synovitis such as rheumatoid arthritis or pigmented villous nodular synovitis
- Joint fibrosis, stiffness, or significantly limited range of motion
- Moderate to severe knee osteoarthritis seen on X-rays
- Failure to complete required rehabilitation protocol
- Medically unfit for surgery, radiographs, or MRI
- Women who are pregnant, planning pregnancy, or breastfeeding
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery plus initial recovery period
Participants undergo autologous osteoperiosteal transplantation surgery to treat severe osteochondral lesions of the talus, followed by immediate post-operative care.
1 surgical visit (in-person)
Duration - Up to 24 months after surgery
Participants attend scheduled follow-up visits to monitor recovery and assess outcomes after surgery.
Visits at 6 weeks, and 3, 6, 12, and 24 months after surgery
Duration - Up to 48 months after surgery
Participants are monitored for complications and long-term outcomes up to 48 months after surgery.
Final follow-up visit at 48 months
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, China
Actively Recruiting
Research Team
Q
Qinwei Guo, MD
Q
Qixian Shen, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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