Clinical trial NCT05971173: Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery
Official title: Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery: A Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Hip Fractures
Keywords: Older adults
Hip surgery
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of surgical complications at 26 weeks
timeFrame: 26 weeks (post surgery)
Secondary outcomes:
measure: Hospital Readmissions
timeFrame: 26 weeks (post surgery)
measure: Secondary fractures
timeFrame: 26 weeks (post surgery)
measure: Grip strength
timeFrame: Baseline to 26 weeks
measure: Quality of Life Survey (Short-form 36 Health (SF-36))
timeFrame: Baseline to 26 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University Health System
state: Texas
city: San Antonio
country: United States
facility: UT Health San Antonio Department of Orthopedics
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Boris Zelle, MD
role: PRINCIPAL_INVESTIGATOR
References: