BFR Therapy Following DRF

Carilion Clinic

Status: Completed

Conditions: Distal Radius Fracture

Treatments: Other: Standard of Care Physical Therapy; Other: Blood Flow Restriction

Study type: Interventional

Funder types: Other

Identifiers

NCT05396521

IRB-21-1514

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4 participants in 2 patient groups

Standard of Care

Active Comparator group

Treatment:

Other: Standard of Care Physical Therapy

Blood Flow Restriction Supplemented

Experimental group

Treatment:

Other: Blood Flow Restriction