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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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XR™ Recovery Supplement | Experimental | 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. Participants will then take the XR™ Recovery Supplement twice daily for three weeks following their surgery. |
|
| Standard nutritional counseling | No Intervention | The control group will receive standard of care nutritional counseling with a registered dietician once during inpatient admission, without the use of the supplement. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Visit 7 (1 year post operation) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Complications include infection and bleeding. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abhishek Ganta, MD | Contact | (951) 492-8945 | Abhishek.ganta@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Abhishek Ganta, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
REDCap data will be reshared with study sponsor in the form of de-identified aggregate data. Data collected for this study will be analyzed and stored at NYU Langone. After the study is completed, any identifiable information collected during the study will not be used or distributed for future research studies.
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| 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. |
|
| Visit 5, up to 6 months |
| 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 | 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. | Baseline, Visit 7 (1 year post operation) |