Using autologous osteoperiosteal transplantation to treat severe ankle cartilage damage

A Multicenter Prospective Cohort Study of Autologous Osteoperiosteal Transplantation for the Treatment of Severe Osteochondral Lesions of the Talus

This study is testing a new surgery using a patient's own bone and tissue to see if it can help people with severe ankle cartilage damage feel better and recover more effectively than current treatments.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Peking University Third Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06527482 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to create a multicenter prospective cohort of patients suffering from severe osteochondral lesions of the talus. It evaluates the clinical efficacy of autologous osteoperiosteal transplantation and assesses the incidence of postoperative donor-site morbidity. Participants will undergo the transplantation procedure and receive clinical follow-ups at 3, 6, 12, and 24 months post-surgery, including imaging assessments and functional evaluations of the ankle. The study seeks to determine if this treatment leads to improved outcomes and fewer complications compared to existing methods.

Who should consider this trial

Good fit: Ideal candidates are individuals with chronic ankle pain due to osteochondral lesions of the talus who have not responded to conservative treatment.

Not a fit: Patients with significant ankle deformities, severe ligament injuries, or other joint conditions may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery and quality of life for patients with severe ankle cartilage damage.

How similar studies have performed: While similar approaches have been explored, this specific method of autologous osteoperiosteal transplantation for severe osteochondral lesions is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Chronic ankle pain, diagnosed as Osteochondral Lesions of the Talus (OLT);
* Hepple V OLT on the medial side of the talus or the diameter of the lesion ≥ 8 mm;
* Conservative treatment of at least 3 months fails to relieve symptoms;
* Willingness to voluntarily participate in the trial and to sign informed consent.

Exclusion Criteria:

* Varus or valgus deformity of the ankle of more than 5 degrees;
* Grade III injury of the lateral collateral ligament of ankle;
* Chronic synovitis (rheumatoid arthritis, pigmented villous nodular synovitis, etc.);
* Joint fibrosis, stiffness, and significantly restricted range of motion;
* Evidence of moderate to severe knee osteoarthritis on plain radiographs;
* Failure to complete the rehabilitation protocol as required;
* Patient medically not fit for surgery, radiographs or MRI;
* For women, pregnant, planning to be pregnant or lactating.

Where this trial is running

Beijing

• Peking University Third Hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Qinwei Guo, MD — Department of Sports Medicine, Peking University Third Hospital
• Study coordinator: Qinwei Guo, MD

Conditions Osteochondral Lesion of Talus; Autologous Osteoperiosteal Transplantation; Arthroscopic Techniques; Clinical Efficacy