Health TrialsbyHealthPanel

Nutritional Supplementation in Geriatric Hip Fractures

ConditionGeriatric Hip Fracture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorNYU Langone Health

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, aged 65 years or older.

Presenting with a geriatric hip fracture (femoral neck, intertrochanteric, or subtrochanteric) requiring surgical intervention.

Able to provide informed consent.

Expected to survive at least 6 months after surgery, with no terminal illness.

Disqualifiers

Pre-existing conditions that significantly impair mobility prior to injury.

Severe renal or liver impairment.

Active treatment with investigational drugs or participation in another clinical trial within the last 30 days.

Inability to tolerate oral nutritional supplementation due to gastrointestinal disorders.

Trial design

Design model

Parallel

Treatments tested in this trial

  • XR™ Recovery Supplement

    Dietary 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.

  • XR Carbohydrate Loading Supplement

    Dietary 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.

Treatment groups

118 Participants
are divided into 2 treatment groups
Group A: XR™ Recovery SupplementExperimental treatment 2 interventions
Group B: Standard nutritional counselingNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Percentage change in muscle loss, as measured by the cross-sectional area of the rectus femoris muscle

Outcome measure will be measured using ultrasound imaging.

Time frame
Baseline, Visit 7 (1 year post operation)

Secondary outcomes

1

Number of inpatient complications related to the surgical procedure for hip fractures

Time frame
From admission (visit 1) until discharge (~72 hours post-operation)
2

Number of wound complications

Complications include infection and bleeding.

Time frame
Visit 5, up to 6 months
3

Length of hospital stay

Time frame
From admission (visit 1) until discharge (~72 hours post-operation)
4

Rate of readmission

Time frame
Visit 7 (1 year post operation)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

Source ClinicalTrials.gov
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