Geriatric Hip Fracture
Conditions
Brief summary
This study is a randomized controlled trial comparing outcomes between geriatric hip fractures who received a commercially available (XR RecoveryTM, Salt Lake City Utah) peri-operative nutritional supplement for three weeks post-operatively to those who receive standard nutritional counseling. The main question it aims to answer is: \- Does supplementation decrease muscle loss via ultrasound measurements of the cross-sectional area of the rectus femoris of the uninjured leg?
Interventions
DIETARY_SUPPLEMENTXR™ Recovery Supplement
Participants will receive a total daily dosage of 59.2 grams of XR™ Recovery Supplement orally, divided into two doses of 29.6 grams each (or two pouches). The dosing regimen will begin upon hospital admission and continue for three weeks post-operatively.
DIETARY_SUPPLEMENTXR Carbohydrate Loading Supplement
2 packets of XR Carbohydrate Loading will be administered the evening before surgery and one packet on the day of surgery up to 2 hours prior to the scheduled operating time. The powder will be mixed with 14 oz of room temperature water only until dissolved then may be served over ice for desired temperature of consumption by the participant.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female, aged 65 years or older. 2. Presenting with a geriatric hip fracture (femoral neck, intertrochanteric, or subtrochanteric) requiring surgical intervention. 3. Able to provide informed consent. 4. Expected to survive at least 6 months after surgery, with no terminal illness.
Exclusion criteria
1. Pre-existing conditions that significantly impair mobility prior to injury. 2. Severe renal or liver impairment. 3. Active treatment with investigational drugs or participation in another clinical trial within the last 30 days. 4. Inability to tolerate oral nutritional supplementation due to gastrointestinal disorders. 5. Allergies to any components of the nutritional supplement being tested.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change in muscle loss, as measured by the cross-sectional area of the rectus femoris muscle | Baseline, Visit 7 (1 year post operation) | Outcome measure will be measured using ultrasound imaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of inpatient complications related to the surgical procedure for hip fractures | From admission (visit 1) until discharge (~72 hours post-operation) | — |
| Number of wound complications | Visit 5, up to 6 months | Complications include infection and bleeding. |
| Length of hospital stay | From admission (visit 1) until discharge (~72 hours post-operation) | — |
| Rate of readmission | Visit 7 (1 year post operation) | — |
| Mortality Rate | Visit 7 (1 year post operation) | — |
| Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score | Baseline, Visit 7 (1 year post operation) | A PROMIS PF score is a measurement of physical function that ranges from 0 to 100. The average score is 50, with a standard deviation of 10. A score of 40 is considered below average, indicating decreased physical function, while a score of 60 is considered above average, which indicates increased physical function. |
Countries
United States
Contacts
CONTACTAbhishek Ganta, MD
PRINCIPAL_INVESTIGATORAbhishek Ganta, MD
NYU Langone Health
Outcome results
None listed