Clinical trial NCT02746458: Rehabilitation Enhanced by Partial Arterial Inflow Restrictions
Official title: REPAIR: Rehabilitation Enhanced by Partial Arterial Inflow Restrictions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Closed Femur Fracture
Keywords: Blood Flow Restriction
Muscle Weakness
Physical therapy techniques
closed femoral fracture injuries
Lead sponsor: Major Extremity Trauma Research Consortium
Sponsor class: OTHER
First posted: 2016-04-21
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Knee Strength measured using a stabilized hand held dynamometer
timeFrame: up to 6 months
measure: Muscle Volume assessed using mid-thigh girth circumference measurement
timeFrame: up to 6 months
Secondary outcomes:
measure: Strength
timeFrame: up to 6 months
measure: Speed
timeFrame: up to 6 months
measure: Speed
timeFrame: up to 6 months
measure: Posture Stability
timeFrame: Change in Functional Performance Measures at 3 months and 6 months
measure: Agility
timeFrame: up to 6 months
measure: Agility
timeFrame: up to 6 months
measure: Physical Function
timeFrame: up to 1 year
measure: Depression evaluated with a depression questionnaire
timeFrame: up to 1 year
measure: Anxiety evaluated with an anxiety questionnaire
timeFrame: up to 1 year
measure: Sleep Disturbance evaluated with a sleep disturbance questionnaire
timeFrame: up to 1 year
measure: Psychological outcome-Post Traumatic Stress (PTSD) measured using the standard PTSD Checklist (PCL)
timeFrame: up to 1 year
measure: Return to Work and Work Productivity measured using the Work Productivity and Activity Impairment (WPAI) questionnaire
timeFrame: up to 1 year
measure: Pain evaluated with a Pain Inference scale
timeFrame: up to 1 year
measure: Satisfaction with Care and Recovery assessed using the MedRisk Instrument for Measuring Patient Satisfaction with Physical Therapy Care (MRPS)
timeFrame: 3 months
measure: Fracture Healing
timeFrame: up to 1 year
measure: Fracture Healing
timeFrame: up to 1 year
measure: Complications
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Methodist Hospital
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth
state: Ohio
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: San Antonio
country: United States
facility: San Antonio Military Medical Center
state: Texas
Study officials:
affiliation: Major Extremity Trauma Research Consortium Coordinating Center
name: Lisa Reider, PhD
role: STUDY_DIRECTOR
affiliation: San Antonio Military Medical Center
name: Daniel J Stinner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Major Extremity Trauma Research Consortium Coordinating Center
name: Ellen J MacKenzie, PhD
role: PRINCIPAL_INVESTIGATOR
References: