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The objective of this multi-center, prospective, placebo-controlled, randomized study is to compare oral conditionally essential amino acid (CEAA) supplementation for decreasing the key postoperative complications of fracture-related infection, fracture nonunion, and skeletal muscle wasting with a placebo control (PC) after lower extremity fracture fixation. Investigators hypothesize that perioperative oral supplementation with an investigational CEAA supplement (ICS) will reduce postoperative fracture-related infections, fracture nonunion rates, and skeletal muscle wasting in patients with traumatic lower extremity fractures. This is supported by strong pilot data. Conducting a randomized controlled trial at five civilian tertiary referral centers and one military treatment facility will further study the potential benefits of oral CEAA supplementation for preventing the stated key postoperative complications in patients following high energy lower extremity orthopedic trauma. This low cost, low risk intervention has demonstrated potential to expedite Warfighter return to duty as well as potentially reducing delayed limb amputations and mortality in severely injured patients.
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
No
Start Date
June 1, 2026
Primary Completion Date
December 31, 2027
Completion Date
December 31, 2027
Last Updated
January 8, 2026
1,000
ESTIMATED participants
CEAA supplementation
DIETARY_SUPPLEMENT
Placebo
OTHER
Lead Sponsor
University of Minnesota
NCT05699174
NCT05381818
Data Source & Attribution
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