← Back to Search

Other

Blood Flow Restriction for Femur Fractures (REPAIR Trial)

N/A
Waitlist Available
Led By Daniel J Stinner, MD
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

REPAIR Trial Summary

This trial will study whether a protocol of partial arterial inflow restriction can help people recovering from a femur fracture.

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.Check my eligibility
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.See study design
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.

REPAIR Trial Eligibility Criteria

Inclusion Criteria

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

REPAIR Trial 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

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

REPAIR 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.

Find a Location

Who is running the clinical trial?

Major Extremity Trauma Research ConsortiumLead Sponsor
30 Previous Clinical Trials
26,776 Total Patients Enrolled
Lisa Reider, PhDStudy DirectorMajor Extremity Trauma Research Consortium Coordinating Center
4 Previous Clinical Trials
1,183 Total Patients Enrolled
Daniel J Stinner, MDPrincipal InvestigatorSan Antonio Military Medical Center

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~28 spots leftby Mar 2025