Trial to Evaluate UltraSound in the Treatment of Tibial Fractures (TRUST)

November 4, 2015 updated by: Bioventus LLC
The purpose of this study is to determine the effect of low-intensity, pulsed ultrasound on tibial fractures treated with intramedullary nailing.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

A randomized, placebo controlled, clinical trial to evaluate the safety and efficacy of low-intensity, pulsed ultrasound, applied to tibial fractures treated with intramedullary nailing.

Study Type

Interventional

Enrollment (Actual)

501

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 Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver Coastal Health
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • QE II Health Sciences Centre
  • United States
    • California
      • San Francisco, California, United States, 94110
        • San Francisco General/Dept of Orthopedic Surgery
    • Florida
      • Tampa, Florida, United States, 33606
        • Florida Orthopedic Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • OrthoIndy
    • Kentucky
      • Lexington, Kentucky, United States, 50436
        • University of Kentucky
    • Maine
      • Bangor, Maine, United States, 04401
        • Eastern Maine Medical Center
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri
    • New York
      • New York, New York, United States, 10065
        • Insall Scott Kelly Institute
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Philadelphia, Pennsylvania, United States, 19107
        • Rothman Institute
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital System
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Orthopedic Specialtiy Associates
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females age 18 years or older
  • Have an open or closed tibial fracture amenable to intramedullary nail fixation

Exclusion Criteria:

  • Tibial fracture associated with a vascular injury requiring repair
  • Pilon fractures
  • Tibial fractures that extend into the joint and require reduction
  • Pathologic fractures • Bilateral tibial fractures

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Exogen 4000+
Single arm, Exogen 4000+
Device: Exogen 4000+
Low-intensity pulsed ultrasound (LIPUS)
Other Names:
  • Exogen Bone Healing System - 4000+ series
Sham Comparator: Sham
Single arm, sham (identical device with the exception of administration of ultrasound).
Device: Sham
sham device identical to active device with the exception of administration of ultrasound
Other Names:
  • Single arm, sham of the Exogen 4000+

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the SF-36 Physical Component Summary (PCS) Score of the Short Form-36 (SF-36)
Time Frame: Over 365 days
Assessments at baseline and 6 post baseline time points/ mixed effects repeated measure single point estimate. Range= -100 worst, 0 best
Over 365 days
Time (Days) to Radiographic Healing of Tibial Fractures
Time Frame: over 365 days
Days from randomization to day of x-ray assessed healed or, if not healed, day of premature withdrawal/study termination or day 365 (end of study visit)/ Kaplan-Meier
over 365 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Compliance
Time Frame: Treatment period: Days from randomization to day of x-ray assessed healed or, if not heal, day of premature withdrawal/study termination or day 365 (end of study visit)
The percent of subjects who used the device greater than or equal to 18 minutes per day over 80% of the days in their treatment period.
Treatment period: Days from randomization to day of x-ray assessed healed or, if not heal, day of premature withdrawal/study termination or day 365 (end of study visit)

Collaborators and Investigators

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

Sponsor

Bioventus LLC

Collaborators

McMaster University
Clinical Advances Through Research and Information Translation

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

September 1, 2008

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

April 21, 2008

First Submitted That Met QC Criteria

April 24, 2008

First Posted (Estimate)

April 28, 2008

Study Record Updates

Last Update Posted (Estimate)

December 8, 2015

Last Update Submitted That Met QC Criteria

November 4, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EX-TIB-0907

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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