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Completed

NCT Number: NCT02746458

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Methodist Hospital, Indianapolis, Indiana, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • Open diaphyseal femur fracture (except low velocity gunshot wounds) or severe crushing injuries to study limb.
  • 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.
  • 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.
  • 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).
  • 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).
  • Use of blood flow restriction (BFR) at any time between treatment and the start of physical therapy for the study.
  • Non-ambulatory pre-injury.
  • Morbidly obese (BMI > 40).
  • History of Peripheral Artery Disease and/or Peripheral Vascular Disease (PAD/PVD).
  • Current or history of venous thromboembolism.
  • Impaired circulation or peripheral vascular compromise.
  • Previous revascularization at the study injury site.
  • Extremities with dialysis access.
  • Current diagnosis of acidosis.
  • Diagnosis of sickle cell anemia.
  • Current infection of the study injury.
  • Current tumor (malignant or benign) distal to study injury and future tourniquet placement.
  • Current use of medications or supplements that are known to increase clotting risk.
  • Diagnosis of severe hypertension (blood pressure of 180/110).
  • Skin grafts in which all bleeding points must be readily distinguished.
  • Secondary or delayed surgical procedures to study injury after immobilization.
  • Vascular grafting to the study injury.
  • History of lymphotomies.
  • Current diagnosis of cancer.
  • Unable to speak either English or Spanish.
  • 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).
  • Unable to provide informed consent.
  • Patient has not been cleared to start physical therapy at the time of consent.
  • Patient is pregnant.
  • Patient received BFR between date of injury and start of Physical Therapy.

Treatment and study plan

Blood Flow Restriction

Other

Brief and intermittent blood flow restriction via a Delfi PTSII Tourniquet System will be used during physical therapy.

Delfi PTSII Tourniquet System

Device

Primary outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Major Extremity Trauma Research Consortium

Other

Registry information

Official study title

REPAIR: Rehabilitation Enhanced by Partial Arterial Inflow Restrictions

Acronym: REPAIR

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2016
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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