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Blood Flow Restriction for Femur Fractures (REPAIR Trial)
REPAIR Trial Summary
This trial will study whether a protocol of partial arterial inflow restriction can help people recovering from a femur fracture.
REPAIR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowREPAIR Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.REPAIR Trial Design
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Who is running the clinical trial?
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- I cannot speak English or Spanish.I am between 18 and 55 years old.I have a dialysis access point in my arm or leg.I haven't had treatments on the injury that would interfere with using a tourniquet.I am currently taking medication or supplements that increase the risk of blood clots.My BMI is over 40.I have been diagnosed with acidosis.I am between 18 and 55 years old.I have not been approved to start physical therapy yet.I am admitted for surgery on a specific type of thigh bone fracture.I have no injuries that would stop me from starting physical therapy within 28 days after treatment.I can start physical therapy and bear weight within 28 days after my surgery.I am scheduled for surgery after being immobilized due to an injury.I received BFR treatment between my injury and starting physical therapy.I have a history of problems with blood flow in my limbs.I have had a vascular graft for my injury.I have been diagnosed with sickle cell anemia.My skin grafts are healed with no active bleeding.I can start physical therapy within 28 days after my limb surgery without other injuries affecting it.I was unable to walk before my injury.I have a severe open fracture or crush injury in my thigh bone.My blood pressure is very high, at or above 180/110.I have or had a blood clot in my veins.I may have trouble following up due to personal circumstances.I am admitted for surgery on a specific type of thigh bone fracture.I have had a procedure to restore blood flow at the injury site.I have had lymph node surgeries in the past.I have poor blood flow in my limbs.I am unable to understand and agree to the study's details on my own.I have used blood flow restriction therapy before starting physical therapy for this study.My current tumor is located away from where a tourniquet would be placed for my study injury.I am currently diagnosed with cancer.
- Group 1: Standard of Care Physical Therapy
- Group 2: Blood Flow Restriction Plus Standard of Care Physical Therapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are any additional participants being sought for this research endeavor?
"Clinicaltrials.gov data indicates that this medical study is no longer recruiting patients, though it was first published on April 1st 2016 and last modified October 12th 2022. Nevertheless, 27 other trials are currently enlisting volunteers."
Who has the eligibility to participate in this experiment?
"To qualify for this medical trial, the participants must have femur and be of legal age. Additionally, 250 people are expected to join the study before it is complete."
What end results is this clinical trial aiming to accomplish?
"This 6 month long trial will evaluate patient Knee Strength via a stabilized hand held dynamometer. Other objectives include measuring Agility with the Illinois Agility Test, Speed through the 40 yard shuttle run, and Psychological outcome-Post Traumatic Stress (PTSD) using the standard PTSD Checklist (PCL)."
How many centers administer this clinical trial?
"As of right now, the trial is recruiting participants at University of Maryland Medical Center in Baltimore, MD; San Antonio Military Medical Center in San Antonio, TX; and Barnes Jewish Hospital in Saint Louis, MO as well as 5 other medical sites."
Does this research endeavor have any age restrictions?
"As established by the trial's inclusion criteria, 18 is the youngest age for enrollment and 55 is the oldest."
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