Hip Fractures
Conditions
Keywords
Older adults, Hip surgery
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.
Interventions
DRUGJuven
Nutritional supplements
DRUGCentrum Silver 50+
Over the counter nutritional supplement
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
1. Provision of signed and dated informed consent form 2. Male or female, aged 65-89 years 3. Closed fracture of the proximal femur including the anatomic areas of femoral neck, intertrochanteric and subtrochanteric region 4. Patient indicated for surgical treatment (surgical fixation or arthroplasty) as per orthopaedic surgeon 5. 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
1. Patients with open fractures 2. Surgical treatment other than surgical fixation or arthroplasty, such as proximal femur resection 3. 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) 4. Decisional impairment 5. Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of surgical complications at 26 weeks | 26 weeks (post surgery) | Number of subjects that experienced any complications post surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Readmissions | 26 weeks (post surgery) | Number of hospital re-admissions |
| Secondary fractures | 26 weeks (post surgery) | Number of secondary fractures that occurred post surgery |
| Grip strength | Baseline to 26 weeks | Change in grip strength from pre- to post-surgery using a hand dynamometer and measured in pounds |
| Quality of Life Survey (Short-form 36 Health (SF-36)) | Baseline to 26 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBoris Zelle, MD
The University of Texas Health Science Center at San Antonio
Outcome results
None listed