Skip to main content
OpenTrials
Completed

NCT Number: NCT05396521

BFR Therapy Following DRF

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Distal Radius Fracture Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carilion Clinic

Roanoke, Virginia, 24014, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Flow Restriction

Other

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.

Standard of care physical therapy

Other

Group 1 (Control) will receive standard of care physical therapy.

Primary outcomes

  1. PROMIS Pain interference SF V1.1

    Time frame: 3 months

  2. PRWE

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Carilion Clinic

Other

Collaborators

  • Virginia Polytechnic Institute and State University

Registry information

Official study title

Utilizing Blood Flow Restriction Therapy Following ORIF Treated Distal Radius Fractures

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 31, 2022
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.