Clinical trial NCT05396521: BFR Therapy Following DRF
Official title: Utilizing Blood Flow Restriction Therapy Following ORIF Treated Distal Radius Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fracture
Keywords: Blood Flow Restriction
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
Collaborators: name: Virginia Polytechnic Institute and State University
First posted: 2022-05-31
Enrollment: 4
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: PROMIS Pain interference SF V1.1
timeFrame: 3 months
measure: PRWE
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
Study officials:
References:
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