Osteochondral; Defect Clinical Trial
Official title:
Clinical Study of Autologous Osteo-periosteal Cylinder Graft Transplantation for Hepple V Osteochondral Lesions of the Talus
| Verified date | April 2023 |
| Source | Peking University Third Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Enrolling by invitation |
| Enrollment | 70 |
| Est. completion date | December 31, 2023 |
| Est. primary completion date | December 31, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Institute of Sports Medicine | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Peking University Third Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | American Orthopaedic Foot & Ankle Society(AOFAS) ankle-hindfoot score | American Orthopaedic Foot & Ankle Society(AOFAS) ankle-hindfoot score. The higher score represent the better outcome. | 4 years | |
| Secondary | International Cartilage Repair Society(ICRS) score | International Cartilage Repair Society(ICRS) score. The higher score represent the better outcome. | 4 years | |
| Secondary | Magnetic Resonance Observation of cartilage repair tissue(MOCART) score | Magnetic Resonance Observation of cartilage repair tissue(MOCART) score. The higher score represent the better outcome. | 4 years | |
| Secondary | Tegner activity level score | The highest level of activity that you participated in before your injury and the highest level you are able to participate in currently. The higher values represent a better outcome. | 4 years | |
| Secondary | Visual analogue scale | The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. From 0 to 10, no pain 0, worst pain imaginable 10. The higher values represent a worse outcome. | 4 years |