A Randomized Open-labeled Controlled Study to Evaluate the Effects of PBS-60 in Improving Muscle Strength and Functional Mobility in Subjects Undergoing Total Knee Arthroplasty (TKA)

Protein and amino acid supplementation is well recognized for its essential role in muscle growth, repair, and strength enhancement ,particularly in the context of orthopedic procedures like total knee arthroplasty (TKA). Proteins, composed of amino acids, are fundamental for muscle protein synthesis (MPS), a process critical for muscle maintenance and growth. Essential amino acids (EAAs) such as leucine, valine, and isoleucine act as key activators of the mTOR pathway, which drives MPS and contributes to increased muscle volume and strength. Numerous studies have highlighted the benefits of protein supplementation in preserving lean muscle mass and enhancing muscle recovery post-surgery, making it especially relevant for individuals undergoing TKA, a surgery often accompanied by a period of reduced mobility and subsequent muscle atrophy for patients recovering from TKA, protein and amino acids not only support muscle repair but also play a significant role in restoring functional mobility .TKA often leads to reduced quadriceps strength and general muscle atrophy, issues that can impede postoperative recovery and affect long-term joint function . Supplementation with protein ,particularly EAAs has been shown to attenuate muscle loss, reduce inflammation, and improve muscle function during recovery.

The study will be conducted over 42 (6 weeks) days and will follow a randomized, open-labeled, controlled study design. Eligible participants will be randomly assigned at a 1:1 ratio to either the control or test group. Participants will receive either standard of care or standard of care plus PBS-60 for 42 days. The primary objective is to evaluate the impact of PBS-60 on improving muscle strength and functional mobility in individuals undergoing TKA. Secondary objective is to evaluate the impact of PBS-60 on pain intensity, and knee society score (KSS) following TKA. Occurrence of adverse events during the study period. The safety assessments are vital signs, physical examination, laboratory assessment and adverse events. Efficacy assessments are visual analogue scale (VAS) for pain intensity, The 2011 knee society scoring system, WHO-5QOL questionnaire, Brief Resilience Scale (BRS) questionnaire, Clinical assessment questionnaire, the western ontario and mcmaster Universities osteoarthritis index (WOMAC) and assessment of functional mobility.