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

Early Phase 1CompletedNCT05971173

The University of Texas Health Science Center at San Antonio40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hip Fractures

Interventions

JuvenDRUG

Nutritional supplements

Centrum Silver 50+DRUG

Over the counter nutritional supplement

Eligibility

Sex: ALLMin age: 65 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Locations (2)

University Health System

San Antonio, Texas, United States

UT Health San Antonio Department of Orthopedics

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Assessment of surgical complications at 26 weeks

Number of subjects that experienced any complications post surgery

Time frame: 26 weeks (post surgery)

Secondary Outcomes

Hospital Readmissions

Number of hospital re-admissions

Time frame: 26 weeks (post surgery)

Secondary fractures

Number of secondary fractures that occurred post surgery

Time frame: 26 weeks (post surgery)

Grip strength

Change in grip strength from pre- to post-surgery using a hand dynamometer and measured in pounds

Time frame: 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.

Time frame: Baseline to 26 weeks

Data from ClinicalTrials.gov

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