Rehabilitation Enhanced by Partial Arterial Inflow Restrictions (REPAIR)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Closed Femur Fracture
• Intervention / Treatment: Other: Blood Flow Restriction; Device: Delfi PTSII Tourniquet System

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Methodist Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Military Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Barnes Jewish Hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolinas Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston
    • San Antonio, Texas, United States, 78219
      • San Antonio Military Medical Center

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): September 1, 2023
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: April 7, 2016
• First Submitted That Met QC Criteria: April 18, 2016
• First Posted (Estimated): April 21, 2016

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Muscle Weakness; Blood Flow Restriction; Physical therapy techniques; closed femoral fracture injuries
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures
• Other Study ID Numbers: W81XWH-15-2-0067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO