Sarcopenia, Total Knee Arthroplasty
Conditions
Keywords
Branched Chain Amino Acids, BCAA, Livact, Skeletal Muscle Mass Index, Bioelectrical Impedance Analysis, Total Knee Arthroplasty, Sarcopenia, Randomized Controlled Trial
Brief summary
This multicenter, prospective, randomized controlled trial evaluates whether postoperative administration of branched chain amino acids affects skeletal muscle mass index and sarcopenia related functional outcomes in patients undergoing total knee arthroplasty. Participants are randomly assigned to receive Livact granules 4.15 g three times daily for 3 months after surgery or to receive standard postoperative care without branched chain amino acid administration. Skeletal muscle mass index, physical function, patient reported outcomes, laboratory findings, medication compliance, and adverse events are assessed at baseline, 5 weeks, and 15 weeks after surgery.
Interventions
DRUGLivact Granule
Livact granules 4.15 g are administered orally, one packet three times daily after meals for 3 months after total knee arthroplasty.
Sponsors
Seoul National University Hospital
Samil Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1\. Patients aged 40 to 100 years who are scheduled to undergo total knee arthroplasty.
Exclusion criteria
1. Participants who used antiretroviral agents within 4 weeks before the first administration of Livact. 2. Participants who used medications associated with fatty liver within 4 weeks before the first administration of Livact, including thiazolidinediones, sodium glucose cotransporter 2 inhibitors, amiodarone, methotrexate, tamoxifen, valproate, or corticosteroids. 3. Participants who used branched chain amino acid products or multinutritional supplements within 4 weeks before the first administration of Livact. 4. Participants who used pain medications other than those prescribed for total knee arthroplasty treatment within 2 weeks before the first administration of Livact. 5. Participants with markedly decreased hepatic protein synthetic function. 6. Participants with congenital branched chain amino acid metabolism disorders. 7. Participants with hereditary galactose intolerance, Lapp lactase deficiency, or glucose galactose malabsorption. 8. Participants with a history of high tibial osteotomy. 9. Participants with neurologic diseases such as stroke or Parkinson disease. 10. Participants with gait disturbance due to causes other than arthritis. 11. Participants taking medication for spinal stenosis. 12. Participants with a history of hypersensitivity to the investigational product or its components. 13. Pregnant or breastfeeding participants. 14. Participants planning pregnancy during the trial or who have the possibility of pregnancy but do not agree to use appropriate contraception during the trial. 15. Participants judged by the investigator to be inappropriate for participation in the clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Skeletal Muscle Mass Index From Baseline to 15 Weeks After Surgery | Baseline and 15 weeks after surgery | Skeletal muscle mass index is calculated from bioelectrical impedance analysis and expressed as kg/m². |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hand Grip Strength From Baseline to 15 Weeks After Surgery | Baseline and 15 weeks after surgery | Hand grip strength is measured using an electronic dynamometer and expressed in kilograms. |
| Change in Five Times Sit to Stand Test Time From Baseline to 15 Weeks After Surgery | Baseline and 15 weeks after surgery | Time required to complete five sit to stand repetitions is measured in seconds. |
| Change in 6 Meter Walk Test Time From Baseline to 15 Weeks After Surgery | Baseline and 15 weeks after surgery | Time required to walk 6 meters is measured in seconds. |
| Change in Lysholm Score From Baseline to 15 Weeks After Surgery | Baseline and 15 weeks after surgery | The Lysholm score is used to assess knee symptoms and function. Scores range from 0 to 100, with higher scores indicating better knee function. |
| Change in Pain Visual Analog Scale Score From Baseline to 15 Weeks After Surgery | Baseline and 15 weeks after surgery | Pain is assessed using a visual analog scale, with higher scores indicating greater pain. |
| Change in Tegner Activity Score From Baseline to 15 Weeks After Surgery | Baseline and 15 weeks after surgery | The Tegner activity score is used to assess physical activity level. Scores range from 0 to 10, with higher scores indicating a higher activity level. |
| Change in WOMAC Score From Baseline to 15 Weeks After Surgery | Baseline and 15 weeks after surgery | The Western Ontario and McMaster Universities Osteoarthritis Index is used to assess pain, stiffness, and physical function. Scores range from 0 to 96, with higher scores indicating worse symptoms. |
| Change in IKDC Subjective Score From Baseline to 15 Weeks After Surgery | Baseline and 15 weeks after surgery | The International Knee Documentation Committee subjective score is used to assess knee symptoms, function, and sports activities. Scores range from 0 to 100, with higher scores indicating better knee function. |
| Change in Skeletal Muscle Mass Index From Baseline to 5 Weeks After Surgery | Baseline and 5 weeks after surgery | Skeletal muscle mass index is calculated from bioelectrical impedance analysis and expressed as kg/m². |
Countries
South Korea
Contacts
CONTACTHyunwoo Kim
PRINCIPAL_INVESTIGATORDu Hyun Ro, MD, PhD
Seoul National University Hospital
Outcome results
None listed