Autologous Osteo-periosteal Cylinder Graft Transplantation for Hepple V Osteochondral Lesions of … (NCT03347877) | Clinical Trial Compass
By InvitationNot Applicable
Autologous Osteo-periosteal Cylinder Graft Transplantation for Hepple V Osteochondral Lesions of the Talus
China70 participantsStarted 2018-01-01
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
American Orthopaedic Foot & Ankle Society(AOFAS) ankle-hindfoot score