Lower Extremity Fracture
Conditions
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.
Interventions
DIETARY_SUPPLEMENTCEAA 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.
OTHERPlacebo
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
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
CONTACTPaula Rupp
CONTACTDoris Stuber
PRINCIPAL_INVESTIGATORNathan Hendrickson
University of Minnesota
Outcome results
None listed