BFR Therapy Following DRF

Study Overview
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Brief Summary
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This study's goal is to evaluate whether blood flow restriction supplemented therapy is a superior therapy compared to traditional standard of care while recovering from a surgery that repairs distal radius fractures. In order to measure this, subjects will be randomly assigned to either the traditional therapy group (with standard of care) or a blood flow restriction supplemented therapy group. All patients involved in this study will have had a distal radius fracture that is repaired with a technique called volar plating and the procedure will be done via an open technique. All subjects will be asked to fill out questionnaires that assess their pain and wrist functionality throughout the course of the study. These measurements will help understand whether the supplemented therapy is effective at reducing pain and improving functionality for patients who are recovering from this injury.

Official Title
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Utilizing Blood Flow Restriction Therapy Following ORIF Treated Distal Radius Fractures

Conditions
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Distal Radius Fracture

Intervention / Treatment
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* Other: Blood Flow Restriction
* Other: Standard of Care Physical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients undergoing distal radius fracture open reduction internal fixation using volar plating (CPT 25607, 25608, and 25609) Age 50 - 75 Fall onto outstretched hand injury Exclusion Criteria: High energy mechanism Fall from an elevated position greater than 12 inches Motor vehicle collision Any activity involving a powered vehicle (scooter, car, truck, ATV, motorcycle, tractor, etc.) any concomitant injury to the affected limb Bilateral distal radius fracture Revision procedures Worker's compensation status Non-English speaking No Internet Access Inability to provide informed consent Patients with known lymphovascular disorders, including peripheral arterial disease (PAD), prior deep vein thrombosis (DVT) or chronic lymphedema Patients with known genetic or other hypercoagulability disorders including those on long-term anticoagulation or anti-platelet therapy (other than prophylactic aspirin) Uncontrolled hypertension Patients with dialysis catheters or AV fistula Any other medical condition that affects the risk profile of the patient or that affects the normal physiologic function of the circulatory system of the extremities, based on sole discretion and medical judgement of the Primary Investigator

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br> | Other: Standard of Care Physical Therapy<br>* Group 1 (Control) will receive standard of care physical therapy.<br>|
| Experimental: Blood Flow Restriction Supplemented<br> | Other: Blood Flow Restriction<br>* Group 2 (experimental) will receive standard of care physical therapy to be done with blood flow restriction therapy (BFR). This method includes standard of care physical therapy while occluding blood flow.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Pain interference SF V1.1 |  | 3 months | 
| PRWE |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Flow Restriction