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Clinical Trials/NCT05396521
NCT05396521
Completed
Not Applicable

Utilizing Blood Flow Restriction Therapy Following ORIF Treated Distal Radius Fractures

Carilion Clinic1 site in 1 country4 target enrollmentMay 26, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Distal Radius Fracture
Sponsor
Carilion Clinic
Enrollment
4
Locations
1
Primary Endpoint
PROMIS Pain interference SF V1.1
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 26, 2022
End Date
May 8, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Peter J Apel

Orthopaedic surgeon

Carilion Clinic

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

Outcomes

Primary Outcomes

PROMIS Pain interference SF V1.1

Time Frame: 3 months

PRWE

Time Frame: 3 months

Study Sites (1)

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