Status:
ACTIVE_NOT_RECRUITING
The Role of Blood Flow Restriction Therapy in Postoperative Elderly Patients With Hip Fracture
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Hip Fractures
Muscle Atrophy
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
The investigators aim to study the use of blood flow restriction therapy (BFR) to augment routine post-operative physical therapy in elderly patients (age \>= 65) after recovering from surgical treatm...
Detailed Description
For elderly patients, a hip fracture is a life-altering event associated with poor overall outcomes despite early surgical treatment. The elderly population and those with significant osteopenia is gr...
Eligibility Criteria
Inclusion
- Age \>= 65 years old, any sex, any ethnicity
- Isolated, closed proximal femur fracture without any prior surgery or orthopedic implants to affected proximal femur. This includes all fractures with primary fracture line that is proximal to the lesser trochanter. For example, subtrochanteric femur fractures are excluded whereas reverse obliquity intertrochanteric femur fractures may be included.
- OTA codes 31A, 31B, and 31C
- Segmental and pathologic femur fractures are excluded.
- Ambulatory without assistive device prior to injury
- Community living prior to injury
- No injury or surgery to the contralateral lower extremity within past 1 year
- Alert and oriented and able to provide informed consent for self
- English speaking
- Able to weight bear as tolerated after surgery as deemed by treating orthopedic surgeon
- Able to tolerate light exercise (could walk approximately 0.5 mile without significant pain or shortness of breath) preoperatively as determined by patient self-reported history
Exclusion
- Presence of other significant injuries at the time of injury to the proximal femur that would require additional surgery
- Significant delay in presentation to health care facility (\>3 days from time of injury) for assessment and treatment of the proximal femur fracture
- History of DVT in any extremity, existing DVT in any extremity, or any condition known to increase risk for coagulopathy including but not exclusively current pregnancy, current diagnosis of cancer/cancer that is being treated
- Current use of any medication or supplement that may increase blood clotting risk
- History of: sickle cell anemia, peripheral arterial disease, dementia, actively treated cancer
- Varicose veins in either lower extremity
- Any significant medical condition that would preclude ability to bear weight as tolerated postoperatively
- Significant cardiac disease as defined by recent stent placement in the past year or presence of implantable pacemaker device
- Morbid obesity (BMI \>40)
- Prior surgery to either lower extremity within one year
- Prior surgery or injury to either lower extremity that would preclude application of a tourniquet and includes but not exclusively: skin grafting, vascular bypass grafting, dialysis site, chronic wound, lymphotomies, varicose vein surgery, presence of tumor)
- Soft tissue injury to either lower extremity that precludes placement of tourniquet
- Diagnosis of uncontrolled hypertension (BP greater than 180/110 on at least two measurements as measured during inpatient stay before surgery)
- Patients with potentially severe problems with maintaining follow-up (ex. Patients who are prisoners, homeless at time of injury, severe dementia, intellectually challenged without adequate family support or have documented significant psychiatric disorder)
- COVID-19 positive
- Admission to ICU postoperatively
- Inadequate postop x-rays placing patient at high risk of implant-related failure
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04809714
Start Date
January 1 2022
End Date
December 31 2026
Last Update
June 8 2025
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35223