Osteochondritis dissecans or articular cartilage injury of the knee Osteochondral autograft transfer or autologous chondrocyte implantation
Conditions
Interventions
NST001 should be taken orally at 1,200 mg twice a day (before breakfast and dinner) for 6 weeks with an appropriate amount of water (about 100~200 mL).
Sponsors
Hirota Yushi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals who are 18 years of age or older at the time of obtaining consent 2. Individuals who are going to receive osteochondral autograft transfer or autologous chondrocyte implantation for osteochondritis dissecans or articular cartilage injury of the knee 3. Individuals who require postoperative immobilization of the knee using knee brace for a week 4. Individuals who can be hospitalized for a month 5. Individuals who have obtained written consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Individuals with severe hepatic impairment (AST or ALT more than 4 times the upper limit of the reference value) 2. Individuals with severe renal impairment (eGFR less than 30 mL/min/1.73 m2) 3. Cancer-bearing individuals 4. Individuals who are taking steroids orally or intravenously at the time of obtaining consent 5. Individuals who have taken metformin, alfa glucosidase inhibitors, H2 blockers, proton pump inhibitors (PPIs), oral antimicrobials, intestinal preparations (bifidobacterium preparations, lactic acid bacteria preparations or butyric acid bacteria preparations), and HYA within 2 months prior to obtaining consent. 6. Individuals with inflammatory bowel disease (ulcerative colitis, Crohn's disease, etc.) or individuals with a history of gastrointestinal (stomach, duodenum, small intestine, large intestine, etc.) resection 7. Individuals with MRI contraindications (e.g., individuals with non-MRI medical devices, claustrophobic individuals)* *: For details, refer to the hospital regulations of the clinical trial site. 8. Pregnant women and individuals who may be pregnant, or who are breastfeeding 9. Individuals who have participated in other clinical trials, interventional or invasive clinical studies within 3 months prior to obtaining consent 10. Other individuals who are judged to be inappropriate by the investigator or co-investigator of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ratio of the change in cross-sectional area of triceps between pre-surgery and 4 weeks after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The ratio of the change in cross-sectional area of triceps among pre-surgery, 1week and 4 weeks after surgery 2) The cross-sectional area of triceps 1 week after surgery 3) The cross-sectional area of triceps 4 weeks after surgery 4) The ratio of the change in fat percentage of triceps among pre-surgery, 1week and 4 weeks after surgery 5) The fat percentage of triceps 1 week after surgery 6) The fat percentage of triceps 4 weeks after surgery 7) The ratio of the change in cross-sectional area of lower leg muscle mass among pre-surgery, 1week and 4 weeks after surgery 8) The cross-sectional area of lower leg muscle mass 1 week after surgery 9) The cross-sectional area of lower leg muscle mass 4 weeks after surgery | — |
Contacts
Public ContactShuichiro Saito
Kobe University Hospital
Outcome results
None listed