The Role of Blood Flow Restriction Therapy in Postoperative Elderly Patients With Hip Fracture

Running, not enrolling · Not applicable

Conditions studied: Hip Fractures, Muscle Atrophy

In brief

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 treatment of hip fractures.

Key facts

Study ID

NCT04809714

Run by

University of Alabama at Birmingham

People needed

20

Starts

2022-01-01

Expected to finish

2027-12-31

Last updated by the study team

2026-01-26

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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