BFR Therapy Following DRF

Not Applicable

Completed

• Conditions: Distal Radius Fracture

• Registration Number: NCT05396521
• Lead Sponsor: Carilion Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-05-25
• Study Start: 2022-05-26
• Study First Posted: 2022-05-31
• Status Verified: 2023-05
• Primary Completion: 2023-05-08
• Study Completion: 2023-05-08
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PROMIS Pain interference SF V1.1	3 months
PRWE	3 months

Trial Locations

Locations (1)

Carilion Clinic; 🇺🇸 Roanoke, Virginia, United States