Status:
NOT_YET_RECRUITING
Perioperative Nutrition Optimization for Reducing Complications After Surgical Fracture Fixation
Lead Sponsor:
University of Minnesota
Conditions:
Lower Extremity Fracture
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- Adults age 18-55 years
- 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)
- Ability to begin supplementation within 72 hours of injury
Exclusion
- 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
- Non-ambulatory prior to injury
- Currently pregnant
- Medical contraindication to CEAA supplementation (e.g., phenylketonuria)
- Inability to provide informed consent due to intellectual disability
- Protected populations (e.g., prisoners)
- Inability to follow up (e.g., homeless at time of surgery, home address out of state of treating facility)
- Documented dementia, mild or moderate traumatic brain injury
- Inability to consume supplement or placebo due to head or neck trauma
- Low-energy fragility fracture (i.e. ground level falls)
- 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)
Key Trial Info
Start Date :
June 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT07155447
Start Date
June 1 2026
End Date
December 31 2027
Last Update
January 8 2026
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