Cartilage defects associated with osteoarthritis of the knee
Conditions
Sponsors
Masato Sato
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria and have the ability to give informed consent 1. 20 to 60 years of age, either male or female 2. Have a cartilage defect of the knee joint 3. Cartilage defect under arthroscopy of greater than or equal to Outerbridge classification Grade III 4. The patellofemoral joint and condyle of the femur must have a cartilage defect or defects which can be fully covered by allogeneic chondrocyte sheets and which have traditionally been treated by marrow stimulation techniques or osteochondral autografts
Exclusion criteria
Exclusion criteria: Patients who meet any one or more of the following criteria will be excluded 1. Obtaining informed consent from the patient is difficult 2. Having complications hindering surgery under general anesthesia or complications affecting knee surgery 3. Having problematic infectious disease (including testing positive for HBV, HCV, HIV, HTLV, FTA-ABS) 4. Having rheumatoid arthritis or other systemic inflammatory disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome Measure of safety: frequency and content of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome Measure of efficacy: 1. Evaluation of the patient self-assessed outcome scores by J-KOOS and clinical evaluation by Lysholm Knee Score 2. X-ray 3. MRI 4. arthroscopic evaluation 5. photoacoustic evaluation 6. pathological evaluation | — |
Countries
Japan
Contacts
Public ContactWatanabe Ayako
Tokai Univercity
Outcome results
None listed