Rehabilitation Enhanced by Partial Arterial Inflow Restrictions (REPAIR)

May 21, 2026 updated by: Major Extremity Trauma Research Consortium

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
219

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
      • St 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hip and Knee Strength measured using a stabilized hand held dynamometer
Time Frame: up to 6 months
Five muscle actions were tested using a handheld dynamometer with the patient in the seated (knee extension, hip flexion), supine (hip abduction), and prone (knee flexion, hip extension) position.
up to 6 months
Muscle Volume assessed using mid-thigh girth circumference measurement
Time Frame: up to 6 months
Two measures of thigh circumference were taken using a flexible measuring tape to estimate muscle volume; one measure was taken at 6 centimeters and one measure taken at 16 centimeters from the superior pole of the patella.
up to 6 months
Hip and Knee Range of Motion
Time Frame: up to 6 months
Four assessments of active joint range of motion (hip and knee flexion and extension) were conducted using a goniometer
up to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Strength
Time Frame: up to 6 months
Strength will be measured using the sit to stand test.
up to 6 months
Speed
Time Frame: up to 6 months
Speed will be evaluated using the self selected walking speed.
up to 6 months
Speed
Time Frame: up to 6 months
Speed will be evaluated using the 40 yard shuttle run.
up to 6 months
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.
Change in Functional Performance Measures at 3 months and 6 months
Agility
Time Frame: up to 6 months
Agility will be measured using the 4 step square test.
up to 6 months
Agility
Time Frame: up to 6 months
Agility will be measured using the Illinois Agility Test.
up to 6 months
Physical Function
Time Frame: up to 1 year
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
Time Frame: up to 1 year
Depression will be evaluated by the Patient Reported Outcomes Measurement Information System depression questionnaire.
up to 1 year
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.
up to 1 year
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.
up to 1 year
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).
up to 1 year
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.
up to 1 year
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.
up to 1 year
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).
3 months
Fracture Healing
Time Frame: up to 1 year
Fracture healing will be determined by clinical examinations.
up to 1 year
Fracture Healing
Time Frame: up to 1 year
Fracture healing will be determined by radiographic examinations.
up to 1 year
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.
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Major Extremity Trauma Research Consortium

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • W81XWH-15-2-0067

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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