BFR Therapy Following DRF

May 25, 2022 updated by: Peter J Apel, Carilion Clinic

Utilizing Blood Flow Restriction Therapy Following ORIF Treated Distal Radius Fractures

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care
Other: Standard of Care Physical Therapy
Group 1 (Control) will receive standard of care physical therapy.
Experimental: Blood Flow Restriction Supplemented
Other: Blood Flow Restriction
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PROMIS Pain interference SF V1.1
Time Frame: 3 months
3 months
PRWE
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carilion Clinic

Collaborators

Virginia Polytechnic Institute and State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2022

Primary Completion (Anticipated)

May 26, 2024

Study Completion (Anticipated)

April 1, 2025

Study Registration Dates

First Submitted

May 25, 2022

First Submitted That Met QC Criteria

May 25, 2022

First Posted (Actual)

May 31, 2022

Study Record Updates

Last Update Posted (Actual)

May 31, 2022

Last Update Submitted That Met QC Criteria

May 25, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-21-1514

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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