Rehabilitation Enhanced by Partial Arterial Inflow Restrictions



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 55
Updated:3/17/2019
Start Date:April 2016
End Date:March 2021
Contact:Elizabeth Wysocki, MS
Email:ewysock2@jhu.edu
Phone:410-955-0396

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REPAIR: Rehabilitation Enhanced by Partial Arterial Inflow Restrictions

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.


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.
We found this trial at
8
sites
Saint Louis, Missouri 63110
Principal Investigator: Chris McAndrew, MD
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Saint Louis, MO
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: Joseph Hsu, MD
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Charlotte, NC
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Joshua Gary, MD
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Houston, TX
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
Principal Investigator: Gerard Slobogean, MD
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Baltimore, MD
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8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Principal Investigator: Benjamin (Kyle) Potter, MD
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Cleveland, Ohio 44109
Principal Investigator: Heather Vallier, MD
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Cleveland, OH
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Indianapolis, Indiana 46202
Principal Investigator: Todd McKinley, MD
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Indianapolis, IN
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San Antonio, Texas
Principal Investigator: Daniel Stinner, MD
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San Antonio, TX
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