Branched Chain Amino Acids for Sarcopenia in Patients Undergoing Total Knee Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Livact Granule.
- Who it may be relevant to
- Registry conditions: Sarcopenia, Total Knee Arthroplasty. Basic parameters: 40 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of BCAA on Sarcopenia in Total Knee Arthroplasty Patients: A Multi-center, Randomized Controlled Trial
Overview
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
- Drug Livact Granule
Livact granules 4.15 g are administered orally, one packet three times daily after meals for 3 months after total knee arthroplasty.
Primary outcome measures
- Change in Skeletal Muscle Mass Index From Baseline to 15 Weeks After Surgery [Time frame: Baseline and 15 weeks after surgery]
Secondary outcome measures (9)
- Change in Hand Grip Strength From Baseline to 15 Weeks After Surgery [Time frame: Baseline and 15 weeks after surgery]
- Change in Five Times Sit to Stand Test Time From Baseline to 15 Weeks After Surgery [Time frame: Baseline and 15 weeks after surgery]
- Change in 6 Meter Walk Test Time From Baseline to 15 Weeks After Surgery [Time frame: Baseline and 15 weeks after surgery]
- Change in Lysholm Score From Baseline to 15 Weeks After Surgery [Time frame: Baseline and 15 weeks after surgery]
- Change in Pain Visual Analog Scale Score From Baseline to 15 Weeks After Surgery [Time frame: Baseline and 15 weeks after surgery]
- Change in Tegner Activity Score From Baseline to 15 Weeks After Surgery [Time frame: Baseline and 15 weeks after surgery]
- Change in WOMAC Score From Baseline to 15 Weeks After Surgery [Time frame: Baseline and 15 weeks after surgery]
- Change in IKDC Subjective Score From Baseline to 15 Weeks After Surgery [Time frame: Baseline and 15 weeks after surgery]
- Change in Skeletal Muscle Mass Index From Baseline to 5 Weeks After Surgery [Time frame: Baseline and 5 weeks after surgery]
Eligibility criteria
Inclusion criteria
1\. Patients aged 40 to 100 years who are scheduled to undergo total knee arthroplasty.
Exclusion criteria
- Participants who used antiretroviral agents within 4 weeks before the first administration of Livact.
- 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.
- Participants who used branched chain amino acid products or multinutritional supplements within 4 weeks before the first administration of Livact.
- Participants who used pain medications other than those prescribed for total knee arthroplasty treatment within 2 weeks before the first administration of Livact.
- Participants with markedly decreased hepatic protein synthetic function.
- Participants with congenital branched chain amino acid metabolism disorders.
- Participants with hereditary galactose intolerance, Lapp lactase deficiency, or glucose galactose malabsorption.
- Participants with a history of high tibial osteotomy.
- Participants with neurologic diseases such as stroke or Parkinson disease.
- Participants with gait disturbance due to causes other than arthritis.
- Participants taking medication for spinal stenosis.
- Participants with a history of hypersensitivity to the investigational product or its components.
- Pregnant or breastfeeding participants.
- Participants planning pregnancy during the trial or who have the possibility of pregnancy but do not agree to use appropriate contraception during the trial.
- Participants judged by the investigator to be inappropriate for participation in the clinical trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 3 centers
- CHA Bundang Medical Center — Seongnam-si
- Seoul National University Hospital — Seoul
- Chung-Ang University Hospital — Seoul
Identifiers
NCT: NCT07634523 · 2402-072-1511