Rehabilitation Enhanced by Partial Arterial Inflow Restrictions

Study Overview
=================
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.

Official Title
-----------------
REPAIR: Rehabilitation Enhanced by Partial Arterial Inflow Restrictions

Conditions
-----------------
Closed Femur Fracture

Intervention / Treatment
-----------------
* Other: Blood Flow Restriction
* Device: Delfi PTSII Tourniquet System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults ages 18-55 inclusive 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: Open diaphyseal femur fracture (except low velocity gunshot wounds) or severe crushing injuries to study limb. 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. 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. 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). 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). Use of blood flow restriction (BFR) at any time between treatment and the start of physical therapy for the study. Non-ambulatory pre-injury. Morbidly obese (BMI > 40). History of Peripheral Artery Disease and/or Peripheral Vascular Disease (PAD/PVD). Current or history of venous thromboembolism. Impaired circulation or peripheral vascular compromise. Previous revascularization at the study injury site. Extremities with dialysis access. Current diagnosis of acidosis. Diagnosis of sickle cell anemia. Current infection of the study injury. Current tumor (malignant or benign) distal to study injury and future tourniquet placement. Current use of medications or supplements that are known to increase clotting risk. Diagnosis of severe hypertension (blood pressure of 180/110). Skin grafts in which all bleeding points must be readily distinguished. Secondary or delayed surgical procedures to study injury after immobilization. Vascular grafting to the study injury. History of lymphotomies. Current diagnosis of cancer. Unable to speak either English or Spanish. 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). Unable to provide informed consent. Patient has not been cleared to start physical therapy at the time of consent. Patient is pregnant. Patient received BFR between date of injury and start of Physical Therapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care Physical Therapy<br>This group will receive the standard of care physical therapy program for 6 weeks. | |
| Experimental: Blood Flow Restriction Plus Standard of Care Physical Therapy<br>This group will receive the same standard of care physical therapy program for 6 weeks plus blood flow restriction. | Other: Blood Flow Restriction<br>* Brief and intermittent blood flow restriction via a Delfi PTSII Tourniquet System will be used during physical therapy.<br>Device: Delfi PTSII Tourniquet System<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Strength measured using a stabilized hand held dynamometer | Knee strength will be measured using a stabilized hand held dynamometer in both the injured and uninjured legs. | up to 6 months | 
| Muscle Volume assessed using mid-thigh girth circumference measurement | Muscle volume will be assessed using mid-thigh girth circumference measurements. | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strength | Strength will be measured using the sit to stand test. | up to 6 months | 
| Speed | Speed will be evaluated using the self selected walking speed. | up to 6 months | 
| Speed | Speed will be evaluated using the 40 yard shuttle run. | up to 6 months | 
| Posture Stability | Postural stability will be evaluated using the single leg stance. | Change in Functional Performance Measures at 3 months and 6 months | 
| Agility | Agility will be measured using the 4 step square test. | up to 6 months | 
| Agility | Agility will be measured using the Illinois Agility Test. | up to 6 months | 
| Physical Function | Physical Function will be evaluated by the Patient Reported Outcomes Measurement Information System physical function questionnaire. | up to 1 year | 
| Depression evaluated with a depression questionnaire | Depression will be evaluated by the Patient Reported Outcomes Measurement Information System depression questionnaire. | up to 1 year | 
| Anxiety evaluated with an anxiety questionnaire | Anxiety will be evaluated by the Patient Reported Outcomes Measurement Information System anxiety questionnaire. | up to 1 year | 
| Sleep Disturbance evaluated with a sleep disturbance questionnaire | Sleep Disturbance will be evaluated by the Patient Reported Outcomes Measurement Information System sleep disturbance questionnaire. | up to 1 year | 
| Psychological outcome-Post Traumatic Stress (PTSD) measured using the standard PTSD Checklist (PCL) | PTSD will be measured using the standard PTSD Checklist (PCL). | up to 1 year | 
| Return to Work and Work Productivity measured using the Work Productivity and Activity Impairment (WPAI) questionnaire | Work productivity will be measured using the Work Productivity and Activity Impairment (WPAI) questionnaire. | up to 1 year | 
| Pain evaluated with a Pain Inference scale | Pain will be evaluated by the Patient Reported Outcomes Measurement Information System Pain Inference scale. | up to 1 year | 
| Satisfaction with Care and Recovery assessed using the MedRisk Instrument for Measuring Patient Satisfaction with Physical Therapy Care (MRPS) | This will be assessed using the MedRisk Instrument for Measuring Patient Satisfaction with Physical Therapy Care (MRPS). | 3 months | 
| Fracture Healing | Fracture healing will be determined by clinical examinations. | up to 1 year | 
| Fracture Healing | Fracture healing will be determined by radiographic examinations. | up to 1 year | 
| Complications | The presence of all limb related complications will be recorded prospectively at each follow up visit, and categorized according to type, date diagnosed, severity, treatment and relation to the study injury. | up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood Flow Restriction, Muscle Weakness, Physical therapy techniques, closed femoral fracture injuries