Nutritional Supplementation in Geriatric Hip Fractures

Not Applicable

Recruiting

• Conditions: Geriatric Hip Fracture

• Registration Number: NCT06773000
• Lead Sponsor: NYU Langone Health

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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Study First Posted: 2025-01-14
• Study Start: 2025-01-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-25
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 118

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Number of inpatient complications related to the surgical procedure for hip fractures	From admission (visit 1) until discharge (~72 hours post-operation)

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States