Cartilage defects associated with osteoarthritis of the knee
Conditions
Interventions
High tibial osteotomy
Autologous cell sheet implantation on cartilage defects
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 79 years of age at the time of giving consent (no restrictions on sex) 2. Patient with osteoarthritis of the knee (with indication for high tibial osteotomy) 3. Written consent from the patient for the participation in the clinical study 4. Cartilage defect under arthroscopy of greater than or equal to Outerbridge classification Grade III 5. Cartilage defect of 1.0 cm^2 or above to less than 8.4 cm^2 located at the condyle of the femur and/or the patellofemoral joint. * Indication criteria for high tibial osteotomy (HTO) 1. Osteoarthritis of the knee on the medial side 2. Intact meniscus and cartilage on the lateral side 3. No or slight osteoarthritis of the patellofemoral joint 4. Femorotibial Angle (FTA) of equal or less than 185 degrees 5. No knee flexion contracture 6. No damage to knee ligaments
Exclusion criteria
Exclusion criteria: Patients who meet any one of the following criteria will be excluded 1. Requires special ethical considerations 2. Has serious heart or respiratory disease 3. Tests positive in preoperative tests for problematic infectious disease such as HBV, HCV, HIV, HTLV-1, syphilis 4. Has had surgical procedures to treat cartilage legions in the past 5. Women who are pregnant or lactating or are possibly pregnant 6. Any other condition deemed seriously problematic to the operation by the principal investigator or co-investigators of this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Measure of efficacy: Evaluation of the patient self-assessed outcome scores at one-year postoperative by J-KOOS (Japanese Knee Injury and Osteoarthritis Outcome Score) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome Measures of efficacy: 1) Histological evaluation of the repair site by biopsy 2) Arthroscopic evaluation 3) Morphological evaluation of the repair site by MRI 4) Clinical evaluation by Lysholm Knee Score Secondary Outcome Measures of safety: Incidence rate of serious adverse events | — |
Countries
Japan
Contacts
Public ContactIzumi Tsuchiya
Tokai Univercity
Outcome results
None listed