NCT07155447

Perioperative Nutrition Optimization for Reducing Complications After Surgical Fracture Fixation

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Lower Extremity Fracture

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	CEAA supplementation	(including calcium beta-hydroxy-beta- methylbutyrate monohydrate, L-Arginine, L-Glutamine and Ciltruline) Supplementation will be started within 72 hours of presentation and continued for a period of 28 days.
OTHER	Placebo	a neutral powder containing the non- essential amino acid Alanine which will be indistinguishable from the CEAA supplement powder in in regards to packaging and supplement appearance.

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-09-04
• Last updated: 2026-01-08