Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Samil Pharmaceutical Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Branched Chain Amino Acid Group | Experimental | Participants receive Livact granules 4.15 g orally three times daily for 3 months after total knee arthroplasty, in addition to standard postoperative care. |
|
| Control Group | No Intervention | Participants receive standard postoperative care without branched chain amino acid administration. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Livact Granule | Drug | Livact granules 4.15 g are administered orally, one packet three times daily after meals for 3 months after total knee arthroplasty. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Skeletal Muscle Mass Index From Baseline to 15 Weeks After Surgery | Skeletal muscle mass index is calculated from bioelectrical impedance analysis and expressed as kg/m². | Baseline and 15 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hand Grip Strength From Baseline to 15 Weeks After Surgery | Hand grip strength is measured using an electronic dynamometer and expressed in kilograms. | Baseline and 15 weeks after surgery |
| Change in Five Times Sit to Stand Test Time From Baseline to 15 Weeks After Surgery |
Not provided
Inclusion Criteria:
1. Patients aged 40 to 100 years who are scheduled to undergo total knee arthroplasty.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyunwoo Kim | Contact | +82-2-6072-5345 | hyunu0331@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Du Hyun Ro, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Bundang Medical Center | Active, not recruiting | Seongnam-si | Gyeonggi-do | 13496 | South Korea | |
Individual participant data will not be shared because the data contain sensitive clinical information and are subject to institutional review board approval, hospital data protection requirements, and participant confidentiality obligations.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000596 | Amino Acids |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Time required to complete five sit to stand repetitions is measured in seconds. |
| Baseline and 15 weeks after surgery |
| Change in 6 Meter Walk Test Time From Baseline to 15 Weeks After Surgery | Time required to walk 6 meters is measured in seconds. | Baseline and 15 weeks after surgery |
| Change in Lysholm Score From Baseline to 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. | Baseline and 15 weeks after surgery |
| Change in Pain Visual Analog Scale Score From Baseline to 15 Weeks After Surgery | Pain is assessed using a visual analog scale, with higher scores indicating greater pain. | Baseline and 15 weeks after surgery |
| Change in Tegner Activity Score From Baseline to 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. | Baseline and 15 weeks after surgery |
| Change in WOMAC Score From Baseline to 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. | Baseline and 15 weeks after surgery |
| Change in IKDC Subjective Score From Baseline to 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. | Baseline and 15 weeks after surgery |
| Change in Skeletal Muscle Mass Index From Baseline to 5 Weeks After Surgery | Skeletal muscle mass index is calculated from bioelectrical impedance analysis and expressed as kg/m². | Baseline and 5 weeks after surgery |
| Seoul National University Hospital |
| Recruiting |
| Seoul |
| Seoul |
| 03080 |
| South Korea |
|
| Chung-Ang University Hospital | Recruiting | Seoul | Seoul | 06973 | South Korea |
|
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |