Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery

Study Overview
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Brief Summary
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The overall objective of this pilot study is to test a comprehensive nutritional intervention in elderly patients diagnosed with hip fracture, which the study team believe will reduce functional decline, morbidity and mortality.

Detailed Description
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This collaborative pilot study is led by a PI who is a board-certified orthopaedic surgeon with extensive experience in the care of older adults with hip fractures. In addition, the multidisciplinary study team includes a research health scientist with vast experience in nutrition, preventive health, and gerontology. The study team will also be supported by a physical therapist and researcher in the field of rehabilitation of older adults with musculoskeletal disorders. Furthermore, an occupational therapist with expertise in rehabilitation science, conduct of pilot studies, and analysis of interview data will play an important role in this study. Moreover, the statistical analyses will be performed by an expert statistical consultant from our institution, who will be reimbursed on a fee for service basis.

Official Title
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Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery: A Pilot Study

Conditions
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Hip Fractures

Intervention / Treatment
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* Drug: Juven
* Drug: Centrum Silver 50+


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form Male or female, aged 65-89 years Closed fracture of the proximal femur including the anatomic areas of femoral neck, intertrochanteric and subtrochanteric region Patient indicated for surgical treatment (surgical fixation or arthroplasty) as per orthopaedic surgeon Ability to take oral medication and be willing to adhere to the study drug regimen and to the nutritional guidance provided by nutritional experts. Exclusion Criteria: Patients with open fractures Surgical treatment other than surgical fixation or arthroplasty, such as proximal femur resection Known allergic reactions to components of the study drugs or who do not tolerate oral nutritional supplementation (e.g. total parenteral nutrition or food allergies) Decisional impairment Prisoners

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional Supplements<br>Juven and Centrum Silver 50+ will be administered to this group | Drug: Juven<br>* Nutritional supplements<br>* Other names: Conditionally essential amino acids;Drug: Centrum Silver 50+<br>* Over the counter nutritional supplement<br>* Other names: Multivitamin/multimineral;|
| No Intervention: Control<br>Standard of care procedures | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of surgical complications at 26 weeks | Number of subjects that experienced any complications post surgery | 26 weeks (post surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Readmissions | Number of hospital re-admissions | 26 weeks (post surgery) | 
| Secondary fractures | Number of secondary fractures that occurred post surgery | 26 weeks (post surgery) | 
| Grip strength | Change in grip strength from pre- to post-surgery using a hand dynamometer and measured in pounds | Baseline to 26 weeks | 
| Quality of Life Survey (Short-form 36 Health (SF-36)) | Change in Health related quality of life (QOL) survey, a 36 item survey. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. | Baseline to 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Older adults, Hip surgery