Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00667849
Recruitment Status : Terminated (Study was terminated due to futility)
First Posted : April 28, 2008
Results First Posted : December 8, 2015
Last Update Posted : December 8, 2015
Sponsor:
Collaborators:
McMaster University
Clinical Advances Through Research and Information Translation
Information provided by (Responsible Party):
Bioventus LLC

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to determine the effect of low-intensity, pulsed ultrasound on tibial fractures treated with intramedullary nailing.

Condition or disease Intervention/treatment Phase
Tibial Fractures Device: Exogen 4000+ Device: Sham Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 501 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trial to Evaluate UltraSound in the Treatment of Tibial Fractures
Study Start Date : September 2008
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Exogen 4000+
Single arm, Exogen 4000+
 Device: Exogen 4000+
Low-intensity pulsed ultrasound (LIPUS)
Other Name: 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 Name: Single arm, sham of the Exogen 4000+


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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

  2. 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


Other Outcome Measures:
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667849


Locations
Layout table for location information
United States, California
San Francisco General/Dept of Orthopedic Surgery
San Francisco, California, United States, 94110
United States, Florida
Florida Orthopedic Institute
Tampa, Florida, United States, 33606
United States, Indiana
OrthoIndy
Indianapolis, Indiana, United States, 46202
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 50436
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
United States, New York
Insall Scott Kelly Institute
New York, New York, United States, 10065
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Greenville Hospital System
Greenville, South Carolina, United States, 29605
United States, Texas
Orthopedic Specialtiy Associates
Fort Worth, Texas, United States, 76104
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Canada, British Columbia
Vancouver Coastal Health
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Nova Scotia
QE II Health Sciences Centre
Halifax, Nova Scotia, Canada
Sponsors and Collaborators
Bioventus LLC
McMaster University
Clinical Advances Through Research and Information Translation
Investigators
Layout table for investigator information
Principal Investigator: Mohit Bhandari, MD McMaster University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Bioventus LLC
ClinicalTrials.gov Identifier: NCT00667849    
Other Study ID Numbers: EX-TIB-0907
First Posted: April 28, 2008    Key Record Dates
Results First Posted: December 8, 2015
Last Update Posted: December 8, 2015
Last Verified: November 2015
Keywords provided by Bioventus LLC:
Tibia
Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries