Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery: A Pilot Study
Overview
- Phase
- Early Phase 1
- Intervention
- Juven
- Conditions
- Hip Fractures
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Assessment of surgical complications at 26 weeks
- Status
- Completed
- Last Updated
- 6 months ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Nutritional Supplements
Juven and Centrum Silver 50+ will be administered to this group
Intervention: Juven
Nutritional Supplements
Juven and Centrum Silver 50+ will be administered to this group
Intervention: Centrum Silver 50+
Outcomes
Primary Outcomes
Assessment of surgical complications at 26 weeks
Time Frame: 26 weeks (post surgery)
Number of subjects that experienced any complications post surgery
Secondary Outcomes
- Hospital Readmissions(26 weeks (post surgery))
- Secondary fractures(26 weeks (post surgery))
- Grip strength(Baseline to 26 weeks)
- Quality of Life Survey (Short-form 36 Health (SF-36))(Baseline to 26 weeks)