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Clinical Trials in China / NCT03347877
Enrolling by invitation Not applicable

Autologous Osteo-periosteal Cylinder Graft Transplantation for Hepple V Osteochondral Lesions of the Talus

NCT03347877 · tracked via the Priya Life Science China tracker
Sponsor
Peking University Third Hospital
Phase
Not applicable
Started
2018-01-01
Last updated
2025-08-27

Condition(s) studied

Osteochondral; Defect

Investigational drug(s) / intervention(s)

autologous osteo-periosteal cylinder graft transplantationautologous osteochondral graft transplantationautologous osteo-periosteal cylinder graft

autologous osteo-periosteal cylinder graft transplantation: Autologous osteo-periosteal cylinder graft transplantation is a novel treatment for Hepple V osteochondral lesions of the talus.

autologous osteochondral graft transplantation: Autologous osteochondral graft transplantation is the most common treatment for Hepple V osteochondral lesions of the talus.

autologous osteo-periosteal cylinder graft: Autologous osteo-periosteal cylinder graft is taken from ilium.

Study summary

The trial evaluates the clinical efficacy and safety of autologous osteo-periosteal cylinder graft transplantation for Hepple V osteochondral lesions of the talus. Half of participants will receive autologous osteo-periosteal cylinder graft transplantation, while the other will receive osteochondral graft transplantation as a control group.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: * 18-50 years old, male or female * Chronic pain in the ankle, confirmed by ankle joint MRI as Hepple V osteo-chondral lesions of the talus * Using rest/external use/oral non-steroidal anti-inflammatory drugs and other conservative treatment for more than 3 months ineffective * Patients voluntarily participated in clinical trials, signed informed consent, with clinical follow-up Exclusion Criteria: * In the last 6 months patients participated in other drug or medical device clinical trials * Line of force in ankle is not correct (varus or valgus\> 5 degrees) * Grade III ankle collateral ligament injury * Chronic specific synovitis (rheumatoid, pigmented villonodular synovitis, etc.) * Joint fibrosis, ankylosis, activity was significantly limited * Moderate and severe osteoarthritis * There are MRI contraindications * Hemophilia patients * The general condition of patients can not tolerate surgery * Pregnant or planned pregnant women and lactating women * Abnormal mental capacity without autonomy * Other conditions in which the doctor can not decide to participate in the trial

Primary outcome measure(s)

  • American Orthopaedic Foot & Ankle Society(AOFAS) ankle-hindfoot score — 4 years
    American Orthopaedic Foot \& Ankle Society(AOFAS) ankle-hindfoot score. The higher score represent the better outcome.

Trial sites (1)

FacilityCityRegionStatus
Institute of Sports Medicine Beijing Beijing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03347877 on ClinicalTrials.gov ↗ ← All trials in China