What side effects are associated with this type of intervention?

Treatments for femur fractures, particularly those involving partial arterial inflow restriction to enhance muscle strength recovery, can have side effects such as increased risk of blood clots, muscle damage, and potential nerve damage due to restricted blood flow. General side effects of femur fracture treatments, including surgical interventions, may also include infection, bleeding, and complications related to anesthesia.

What prior FDA approvals exist?

There is limited specific information on FDA-approved treatments for femur fractures that utilize mechanisms similar to Partial Arterial Inflow Restriction (PAIR). Generally, femur fractures are treated with surgical interventions such as internal fixation, intramedullary nailing, or external fixation, followed by rehabilitation protocols to restore muscle strength and function. While PAIR is being studied for its potential to enhance muscle strength recovery by limiting blood flow, traditional treatments focus on stabilizing the fracture and promoting bone healing through surgical and physical therapy methods.

What other types of research exist?

Promising novel alternatives to Partial Arterial Inflow Restriction for femur fracture patients include: 1) Electrical Muscle Stimulation (EMS), which uses electrical impulses to stimulate muscle contractions and enhance recovery. 2) Blood Flow Restriction (BFR) training, which involves using cuffs to restrict blood flow during low-intensity exercise, promoting muscle hypertrophy and strength. 3) Regenerative medicine approaches such as Platelet-Rich Plasma (PRP) therapy and stem cell therapy, which aim to accelerate healing and improve muscle function. 4) Advanced robotic-assisted rehabilitation devices that provide precise, controlled movements to aid in muscle recovery and strength building.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

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.

0 / 29Eligibility criteria met

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.