Rehabilitation Enhanced by Partial Arterial Inflow Restrictions

Not Applicable

Active, not recruiting

• Conditions: Closed Femur Fracture
• Interventions: Other: Blood Flow Restriction; Device: Delfi PTSII Tourniquet System

• Registration Number: NCT02746458
• Lead Sponsor: Major Extremity Trauma Research Consortium

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-01
• Study First Submitted: 2016-04-07
• Study First Submitted QC: 2016-04-18
• Study First Posted: 2016-04-21
• Primary Completion: 2023-09-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blood Flow Restriction Plus Standard of Care Physical Therapy	Blood Flow Restriction	This group will receive the same standard of care physical therapy program for 6 weeks plus blood flow restriction.
Blood Flow Restriction Plus Standard of Care Physical Therapy	Delfi PTSII Tourniquet System	This group will receive the same standard of care physical therapy program for 6 weeks plus blood flow restriction.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Speed	up to 6 months	Speed will be evaluated using the 40 yard shuttle run.
Agility	up to 6 months	Agility will be measured using the Illinois Agility Test.
Return to Work and Work Productivity measured using the Work Productivity and Activity Impairment (WPAI) questionnaire	up to 1 year	Work productivity will be measured using the Work Productivity and Activity Impairment (WPAI) questionnaire.
Fracture Healing	up to 1 year	Fracture healing will be determined by radiographic examinations.
Strength	up to 6 months	Strength will be measured using the sit to stand test.
Physical Function	up to 1 year	Physical Function will be evaluated by the Patient Reported Outcomes Measurement Information System physical function questionnaire.
Complications	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.
Posture Stability	Change in Functional Performance Measures at 3 months and 6 months	Postural stability will be evaluated using the single leg stance.
Depression evaluated with a depression questionnaire	up to 1 year	Depression will be evaluated by the Patient Reported Outcomes Measurement Information System depression questionnaire.
Sleep Disturbance evaluated with a sleep disturbance questionnaire	up to 1 year	Sleep Disturbance will be evaluated by the Patient Reported Outcomes Measurement Information System sleep disturbance questionnaire.
Pain evaluated with a Pain Inference scale	up to 1 year	Pain will be evaluated by the Patient Reported Outcomes Measurement Information System Pain Inference scale.
Anxiety evaluated with an anxiety questionnaire	up to 1 year	Anxiety will be evaluated by the Patient Reported Outcomes Measurement Information System anxiety questionnaire.
Satisfaction with Care and Recovery assessed using the MedRisk Instrument for Measuring Patient Satisfaction with Physical Therapy Care (MRPS)	3 months	This will be assessed using the MedRisk Instrument for Measuring Patient Satisfaction with Physical Therapy Care (MRPS).
Psychological outcome-Post Traumatic Stress (PTSD) measured using the standard PTSD Checklist (PCL)	up to 1 year	PTSD will be measured using the standard PTSD Checklist (PCL).

Trial Locations

Locations (8)

Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States

MetroHealth; 🇺🇸 Cleveland, Ohio, United States

University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States

Barnes Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States

San Antonio Military Medical Center; 🇺🇸 San Antonio, Texas, United States