Rehabilitation Enhanced by Partial Arterial Inflow Restrictions

Completed · Not applicable

Conditions studied: Closed Femur Fracture

In brief

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.

Key facts

Study ID

NCT02746458

Run by

Major Extremity Trauma Research Consortium

People needed

219

Starts

2016-04-01

Expected to finish

2023-09-30

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Methodist Hospital — Indianapolis, Indiana, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• Barnes Jewish Hospital — St Louis, Missouri, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• MetroHealth — Cleveland, Ohio, United States
• University of Texas Health Science Center at Houston — Houston, Texas, United States
• San Antonio Military Medical Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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