Status:
RECRUITING
Essential Amino Acid Supplementation for Femoral Fragility Fractures
Lead Sponsor:
Michael C Willey
Collaborating Sponsors:
MEND
Slocum Research & Education Foundation
Conditions:
Femoral Fracture
Fragility Fracture
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
This trial will evaluate the impact of 4 weeks of postoperative essential amino acid (EAA)-based supplementation on muscle morphology after femoral fragility fracture. This trial will assess the abili...
Detailed Description
This study consists of 7 study visits that occur over 6 months after operative fixation of femoral fragility fracture. Consenting participants will be asked to complete the study assessments/procedure...
Eligibility Criteria
Inclusion
- Hospital inpatient
- Age ≥ 65 years old on admission
- Low-energy mechanism of injury
- Diagnosis of femur fracture (OTA 31, 32, or 33 fracture)
- Indicated for surgical fixation
- Able to provide informed consent
Exclusion
- Part of a vulnerable population (ex: Incarcerated, Non-English speaking)
- Cognitive impairment (MMSE score ≤ 17)
- Electrical medical implant (ex: Pacemaker/Defibrillator, Left Ventricular Assist Device, Cochlear implant, Insulin pump, Pain medication pumps, Spinal cord stimulator)
- Non-ambulatory prior to injury
- Inability to consume an oral diet or allergy to supplement ingredients (ex: milk allergy)
- Concern for inability to complete follow-up
- Hemi or total arthroplasty (joint replacement)
- Patients with a historical diagnosis of chronic kidney disease (CKD)
Key Trial Info
Start Date :
June 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06050668
Start Date
June 17 2024
End Date
December 1 2025
Last Update
July 17 2024
Active Locations (2)
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1
University of Iowa Health Care
Iowa City, Iowa, United States, 52242
2
Slocum Center for Orthopedics & Sports Medicine
Eugene, Oregon, United States, 97401