Cartilage defects associated with osteoarthritis of the knee Osteoarthritis of the knee High tibial osteotomy
Conditions
Sponsors
Sato Masato
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. Written consent must be obtained from the patient regarding participation in the clinical research 4. Cartilage defect under arthroscopy of greater than or equal to Outerbridge classification Grade III 5. The patellofemoral joint and condyle of the femur must have a cartilage defect or defects which can be fully coverd by allogeneic chondrocyte sheets and which have traditionally been treated by marrow simulation techniques or osteohondral autografts
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria will not be included. 1. Patients for whom it is difficult to obtain informed consent 2. Patients with complications that may interfere with general anesthesia surgery or that may affect knee surgery 3. Those with problematic infectious diseases (including positive for HBV, HCV, HIV, HTLV-1, syphilis, etc.) 4. Those with a history of surgical treatment for cartilage lesions 5. Women who are pregnant or may be pregnant, or women who are breastfeeding 6. Other cases that the clinical research director or research co-investigator judges to be causing serious hindrance to the treatment in this clinical study or that may cause serious hindrance to the treatment.
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 safety: Types of non-severe adverse events and frequency Secondary outcome Measure of efficacy: 1.Evaluation of the patient self-assessed outcome scores by J-KOOS and clinical evalution by Lysholm Knee Score 2.X-ray 3.MRI 4.arthroscopic evaluation 5.pathological evaluation | — |
Countries
Japan
Contacts
Public ContactAyumi Takashima
Tokai University
Outcome results
None listed