Rehabilitation Enhanced by Partial Arterial Inflow Restrictions (REPAIR)

• ClinicalTrials.gov Identifier: NCT02746458
• Recruitment Status: Active, not recruiting
• First Posted: April 21, 2016
• Last Update Posted: October 13, 2022
• Sponsor: Major Extremity Trauma Research Consortium
• Information provided by (Responsible Party): Major Extremity Trauma Research Consortium

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Closed Femur Fracture	Other: Blood Flow Restriction; Device: Delfi PTSII Tourniquet System	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: REPAIR: Rehabilitation Enhanced by Partial Arterial Inflow Restrictions
• Actual Study Start Date: April 1, 2016
• Estimated Primary Completion Date: September 1, 2023
• Estimated Study Completion Date: December 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Strength [ Time Frame: up to 6 months ]
   Strength will be measured using the sit to stand test.
2. Speed [ Time Frame: up to 6 months ]
   Speed will be evaluated using the self selected walking speed.
3. Speed [ Time Frame: up to 6 months ]
   Speed will be evaluated using the 40 yard shuttle run.
4. Posture Stability [ Time Frame: Change in Functional Performance Measures at 3 months and 6 months ]
   Postural stability will be evaluated using the single leg stance.
5. Agility [ Time Frame: up to 6 months ]
   Agility will be measured using the 4 step square test.
6. Agility [ Time Frame: up to 6 months ]
   Agility will be measured using the Illinois Agility Test.
7. Physical Function [ Time Frame: up to 1 year ]
   Physical Function will be evaluated by the Patient Reported Outcomes Measurement Information System physical function questionnaire.
8. Depression evaluated with a depression questionnaire [ Time Frame: up to 1 year ]
   Depression will be evaluated by the Patient Reported Outcomes Measurement Information System depression questionnaire.
9. Anxiety evaluated with an anxiety questionnaire [ Time Frame: up to 1 year ]
   Anxiety will be evaluated by the Patient Reported Outcomes Measurement Information System anxiety questionnaire.
10. Sleep Disturbance evaluated with a sleep disturbance questionnaire [ Time Frame: up to 1 year ]
    Sleep Disturbance will be evaluated by the Patient Reported Outcomes Measurement Information System sleep disturbance questionnaire.
11. Psychological outcome-Post Traumatic Stress (PTSD) measured using the standard PTSD Checklist (PCL) [ Time Frame: up to 1 year ]
    PTSD will be measured using the standard PTSD Checklist (PCL).
12. Return to Work and Work Productivity measured using the Work Productivity and Activity Impairment (WPAI) questionnaire [ Time Frame: up to 1 year ]
    Work productivity will be measured using the Work Productivity and Activity Impairment (WPAI) questionnaire.
13. Pain evaluated with a Pain Inference scale [ Time Frame: up to 1 year ]
    Pain will be evaluated by the Patient Reported Outcomes Measurement Information System Pain Inference scale.
14. Satisfaction with Care and Recovery assessed using the MedRisk Instrument for Measuring Patient Satisfaction with Physical Therapy Care (MRPS) [ Time Frame: 3 months ]
    This will be assessed using the MedRisk Instrument for Measuring Patient Satisfaction with Physical Therapy Care (MRPS).
15. Fracture Healing [ Time Frame: up to 1 year ]
    Fracture healing will be determined by clinical examinations.
16. Fracture Healing [ Time Frame: up to 1 year ]
    Fracture healing will be determined by radiographic examinations.
17. Complications [ Time Frame: up to 1 year ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Indiana

Methodist Hospital

Indianapolis, Indiana, United States, 46202

United States, Maryland

University of Maryland Medical Center

Baltimore, Maryland, United States, 21201

Walter Reed National Military Medical Center

Bethesda, Maryland, United States, 20889

United States, Missouri

Barnes Jewish Hospital

Saint Louis, Missouri, United States, 63110

United States, North Carolina

Carolinas Medical Center

Charlotte, North Carolina, United States, 28204

United States, Ohio

MetroHealth

Cleveland, Ohio, United States, 44109

United States, Texas

University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

San Antonio Military Medical Center

San Antonio, Texas, United States, 78219

Sponsors and Collaborators

Major Extremity Trauma Research Consortium

Investigators

• Study Director: Lisa Reider, PhD; Major Extremity Trauma Research Consortium Coordinating Center
• Principal Investigator: Daniel J Stinner, MD; San Antonio Military Medical Center
• Principal Investigator: Ellen J MacKenzie, PhD; Major Extremity Trauma Research Consortium Coordinating Center

More Information

• Responsible Party: Major Extremity Trauma Research Consortium
• ClinicalTrials.gov Identifier: NCT02746458
• Other Study ID Numbers: W81XWH-15-2-0067
• First Posted: April 21, 2016
• Last Update Posted: October 13, 2022
• Last Verified: October 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Major Extremity Trauma Research Consortium:

Blood Flow Restriction; Muscle Weakness; Physical therapy techniques; closed femoral fracture injuries

Additional relevant MeSH terms:

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Leg Injuries