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Blood Flow Restriction for Femur Fractures (REPAIR Trial)

N/A
Waitlist Available
Led By Ellen J MacKenzie, PhD
Research Sponsored by Major Extremity Trauma Research Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults ages 18-55 inclusive
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)
Must not have
Extremities with dialysis access
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a special physical therapy that partially restricts blood flow to help thigh muscles get stronger in patients recovering from thigh bone fractures. This method has been shown to increase muscle strength and size by limiting blood flow during exercise.

Who is the study for?
This trial is for adults aged 18-55 who are recovering from a specific type of femur fracture (closed diaphyseal with OTA codes: 32A, 32B, or 32C) and treated with an IM Nail. Exclusions include severe additional injuries, obesity (BMI >40), certain medical conditions like sickle cell anemia or acidosis, clotting risk factors, inability to follow up due to social circumstances, non-English/Spanish speakers, pregnancy, prior BFR use post-injury.
What is being tested?
The REPAIR Study tests the Delfi PTSII Tourniquet System's effectiveness in enhancing muscle recovery after a traumatic femur fracture. It uses Blood Flow Restriction therapy during rehabilitation to potentially improve muscle strength more than traditional physical therapy alone.
What are the potential side effects?
Potential side effects may include discomfort at the tourniquet application site, temporary numbness or tingling in the limb due to restricted blood flow. There could also be risks associated with reduced circulation such as bruising or swelling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 55 years old.
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I am admitted for surgery on a specific type of thigh bone fracture.
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I am admitted for surgery on a specific type of thigh bone fracture.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a dialysis access point in my arm or leg.
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I haven't had treatments on the injury that would interfere with using a tourniquet.
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I am currently taking medication or supplements that increase the risk of blood clots.
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I cannot speak English or Spanish.
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My BMI is over 40.
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I have been diagnosed with acidosis.
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I have not been approved to start physical therapy yet.
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I can start physical therapy and bear weight within 28 days after my surgery.
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My skin grafts are healed with no active bleeding.
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I received BFR treatment between my injury and starting physical therapy.
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I have had a procedure to restore blood flow at the injury site.
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I have been diagnosed with sickle cell anemia.
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I have had lymph node surgeries in the past.
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I have used blood flow restriction therapy before starting physical therapy for this study.
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I can start physical therapy within 28 days after my limb surgery without other injuries affecting it.
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I was unable to walk before my injury.
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My blood pressure is very high, at or above 180/110.
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I have had a vascular graft for my injury.
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I may have trouble following up due to personal circumstances.
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I am unable to understand and agree to the study's details on my own.
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I have a severe open fracture or crush injury in my thigh bone.
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I have a history of problems with blood flow in my limbs.
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I have or had a blood clot in my veins.
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I have poor blood flow in my limbs.
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My current tumor is located away from where a tourniquet would be placed for my study injury.
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I am currently diagnosed with cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Knee Strength measured using a stabilized hand held dynamometer
Muscle Volume assessed using mid-thigh girth circumference measurement
Secondary study objectives
Agility
Anxiety evaluated with an anxiety questionnaire
Complications
+11 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Blood Flow Restriction Plus Standard of Care Physical TherapyExperimental Treatment2 Interventions
This group will receive the same standard of care physical therapy program for 6 weeks plus blood flow restriction.
Group II: Standard of Care Physical TherapyActive Control1 Intervention
This group will receive the standard of care physical therapy program for 6 weeks.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for femur fractures include surgical interventions such as intramedullary nailing and plating. Intramedullary nailing involves inserting a rod into the marrow canal of the femur to stabilize the bone, while plating involves attaching a metal plate to the bone with screws. These methods promote proper alignment and stabilization, which are crucial for effective healing. The REPAIR study focuses on Partial Arterial Inflow Restriction, which limits blood flow to enhance muscle strength recovery. This method is significant for femur fracture patients as it aims to address persistent muscle weakness, thereby improving rehabilitation outcomes and overall functional recovery.
A comparison of outcomes between Canada and the United States in patients recovering from hip fracture repair: secondary analysis of the FOCUS trial.Adult respiratory distress syndrome, pneumonia, and mortality following thoracic injury and a femoral fracture treated either with intramedullary nailing with reaming or with a plate. A comparative study.

Find a Location

Who is running the clinical trial?

Major Extremity Trauma Research ConsortiumLead Sponsor
31 Previous Clinical Trials
27,206 Total Patients Enrolled
Ellen J MacKenzie, PhDPrincipal InvestigatorMajor Extremity Trauma Research Consortium Coordinating Center
1 Previous Clinical Trials
500 Total Patients Enrolled
Lisa Reider, PhDStudy DirectorMajor Extremity Trauma Research Consortium Coordinating Center
4 Previous Clinical Trials
1,183 Total Patients Enrolled

Media Library

REPAIR Protocol (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02746458 — N/A
Femur Fractures Research Study Groups: Standard of Care Physical Therapy, Blood Flow Restriction Plus Standard of Care Physical Therapy
Femur Fractures Clinical Trial 2023: REPAIR Protocol Highlights & Side Effects. Trial Name: NCT02746458 — N/A
REPAIR Protocol (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02746458 — N/A
~26 spots leftby Oct 2025