Closed Femur Fracture
Conditions
Keywords
Blood Flow Restriction, Muscle Weakness, Physical therapy techniques, closed femoral fracture injuries
Brief summary
The Rehabilitation Enhanced by Partial Arterial Inflow Restriction (REPAIR) Study will be conducted in a patient population of individuals recovering from a traumatic diaphyseal fracture of the femur. Although the intervention can be used for any patient with muscle weakness following trauma, the persistent thigh weakness that follows a femur fracture provides a perfect model for evaluating the effectiveness of the REPAIR protocol.
Interventions
OTHERBlood Flow Restriction
Brief and intermittent blood flow restriction via a Delfi PTSII Tourniquet System will be used during physical therapy.
DEVICEDelfi PTSII Tourniquet System
Sponsors
Major Extremity Trauma Research Consortium
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Adults ages 18-55 inclusive 2. Admitted to one of the participating clinical centers for operative treatment of a closed diaphyseal femur fracture with one of the following OTA codes: 32A, 32B or 32C (treated with an IM Nail).
Exclusion criteria
1. Open diaphyseal femur fracture (except low velocity gunshot wounds) or severe crushing injuries to study limb. 2. Additional fracture, dislocations or soft tissue injuries to the study limb that would compromise the ability to weight bear as tolerated and initiate PT within 28 days of definitive fixation. 3. Any fractures, dislocations or soft tissue injuries to the contralateral limb or pelvis that would compromise the ability to weight bear as tolerated and initiate PT within 28 days of definitive fixation. 4. Any treatment of the study injury in either group that would preclude application of the tourniquet cuff (e.g. vascular reconstruction, wound, flap, or skin graft). 5. Injuries to other body systems (or other medical conditions) that would preclude the ability to weight bear as tolerated and initiate PT within 28 days of definitive fixation (e.g. spinal cord deficit; severe traumatic brain injury). 6. Use of blood flow restriction (BFR) at any time between treatment and the start of physical therapy for the study. 7. Non-ambulatory pre-injury. 8. Morbidly obese (BMI \> 40). 9. History of Peripheral Artery Disease and/or Peripheral Vascular Disease (PAD/PVD). 10. Current or history of venous thromboembolism. 11. Impaired circulation or peripheral vascular compromise. 12. Previous revascularization at the study injury site. 13. Extremities with dialysis access. 14. Current diagnosis of acidosis. 15. Diagnosis of sickle cell anemia. 16. Current infection of the study injury. 17. Current tumor (malignant or benign) distal to study injury and future tourniquet placement. 18. Current use of medications or supplements that are known to increase clotting risk. 19. Diagnosis of severe hypertension (blood pressure of 180/110). 20. Skin grafts in which all bleeding points must be readily distinguished. 21. Secondary or delayed surgical procedures to study injury after immobilization. 22. Vascular grafting to the study injury. 23. History of lymphotomies. 24. Current diagnosis of cancer. 25. Unable to speak either English or Spanish. 26. Severe problems with maintaining follow-up (e.g. patients who are prisoners, homeless at the time of injury, who are intellectually challenged without adequate family support, or have document psychiatric disorders). 27. Unable to provide informed consent. 28. Patient has not been cleared to start physical therapy at the time of consent. 29. Patient is pregnant. 30. Patient received BFR between date of injury and start of Physical Therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hip and Knee Strength measured using a stabilized hand held dynamometer | up to 6 months | Five muscle actions were tested using a handheld dynamometer with the patient in the seated (knee extension, hip flexion), supine (hip abduction), and prone (knee flexion, hip extension) position. |
| Muscle Volume assessed using mid-thigh girth circumference measurement | up to 6 months | Two measures of thigh circumference were taken using a flexible measuring tape to estimate muscle volume; one measure was taken at 6 centimeters and one measure taken at 16 centimeters from the superior pole of the patella. |
| Hip and Knee Range of Motion | up to 6 months | Four assessments of active joint range of motion (hip and knee flexion and extension) were conducted using a goniometer |
Countries
United States
Contacts
STUDY_DIRECTORLisa Reider, PhD
Major Extremity Trauma Research Consortium Coordinating Center
PRINCIPAL_INVESTIGATORDaniel J Stinner, MD
San Antonio Military Medical Center
PRINCIPAL_INVESTIGATOREllen J MacKenzie, PhD
Major Extremity Trauma Research Consortium Coordinating Center
Outcome results
None listed