Perioperative Nutrition Optimization for Reducing Complications After Surgical Fracture Fixation

NCT ID: NCT07155447

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-06-01
• Study Completion Date: 2027-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patients randomized to CEAA

Patients with lower extremity fractures indicated for operative fracture fixation at six tertiary trauma centers

Group Type: EXPERIMENTAL

CEAA supplementation

Intervention Type: DIETARY_SUPPLEMENT

(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.

patients randomized to placebo

Patients with with lower extremity fractures indicated for operative fracture fixation at six tertiary trauma centers

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Adults age 18-55 years

2. Open or closed fracture of the lower extremity including femur, tibia and/or fibula, calcaneus, talus, Lisfranc joint (OTA/AO 31, 32, 33, 41, 42, 43, 44, 4F, 81, 82, 83, 85)

3. Ability to begin supplementation within 72 hours of injury

Exclusion Criteria

1. BMI <18.5 kg/m 2 (underweight) or BMI > 45 kg/m 2 (severe obesity) to exclude patients with severely increased baseline risk of adverse outcome due to preoperative poor nutrition

2. Non-ambulatory prior to injury

3. Currently pregnant

4. Medical contraindication to CEAA supplementation (e.g., phenylketonuria)

5. Inability to provide informed consent due to intellectual disability

6. Protected populations (e.g., prisoners)

7. Inability to follow up (e.g., homeless at time of surgery, home address out of state of treating facility)

8. Documented dementia, mild or moderate traumatic brain injury

9. Inability to consume supplement or placebo due to head or neck trauma

10. Low-energy fragility fracture (i.e. ground level falls)

11. Pathologic fracture (i.e. fracture through site of compromised bone due to infection, neoplasm, documented osteoporosis, metabolic bone disease from conditions such as end stage renal disease, osteomalacia, hypophosphatemic rickets, renal osteodystrophy, osteofibrous dysplasia)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathan Hendrickson

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Central Contacts

Paula Rupp

Role: CONTACT

mill3725@umn.edu

612-626-3952

Other Identifiers

33444

Identifier Type: -

Identifier Source: org_study_id