Status:

ENROLLING_BY_INVITATION

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

Lead Sponsor:

Peking University Third Hospital

Conditions:

Osteochondral; Defect

Eligibility:

All Genders

18-60 years

Phase:

NA

Brief 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 au...

Detailed Description

Autologous osteo-periosteal cylinder graft surface is a periosteal structure, with the ability of repairment to cartilage, periosteum is closely connected to the cortical bone, then the deep loose can...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT03347877

Start Date

January 1 2018

End Date

December 31 2026

Last Update

August 27 2025

Active Locations (1)

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1

Institute of Sports Medicine

Beijing, Beijing Municipality, China, 100000