Perioperative Nutrition Optimization for Reducing Complications After Surgical Fracture Fixation

Not Applicable

Not yet recruiting

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.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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)

Primary Outcome Measures

Name	Time	Method
Compare clinical benefit of oral supplementation with CEAA versus a placebo for reducing fracture-related infection after lower extremity fracture fixation.	12 months	Investigators will record the number of participants with fracture-related infection for 12 months following lower extremity fracture fixation. The measurement will be based on Metsemakers consensus definition (Metsemakers et al. (2018). We will enroll 1,000 participants and anticipate 15% loss to attrition (426 in each arm). Using the observed fracture-related infection rates of 16.5% and 10% from a previous study, 426 participants would be needed for each group to detect a significant difference with 80% power and alpha value of 0.05 based upon Pearson Chi-Square test and pooled standard deviation.

Secondary Outcome Measures

Name	Time	Method