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Rehabilitation Enhanced by Partial Arterial Inflow Restrictions

United States250 participantsStarted 2016-04-01

Plain-language summary

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.

Who can participate

Age range18 Years – 55 Years

SexALL

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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).

What they're measuring

Knee Strength measured using a stabilized hand held dynamometer

Timeframe: up to 6 months

Muscle Volume assessed using mid-thigh girth circumference measurement

Timeframe: up to 6 months

Trial details

NCT IDNCT02746458

SponsorMajor Extremity Trauma Research Consortium

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-01

View on ClinicalTrials.gov More Closed Femur Fracture trials