MedTrace Logo

Perioperative Nutrition Optimization for Reducing Complications After Surgical Fracture Fixation

NCT07155447 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2026-01-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Nathan Hendrickson · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-12-31
Completion
2027-12-31

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07155447 on ClinicalTrials.gov