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

This study has been terminated.
(Study was terminated due to futility)
Sponsor:
Collaborators:
McMaster University
Clinical Advances Through Research and Information Translation
Information provided by (Responsible Party):
Bioventus LLC
ClinicalTrials.gov Identifier:
NCT00667849
First received: April 21, 2008
Last updated: November 4, 2015
Last verified: November 2015
  Purpose
The purpose of this study is to determine the effect of low-intensity, pulsed ultrasound on tibial fractures treated with intramedullary nailing.

Condition Intervention
Tibial Fractures
Device: Exogen 4000+
Device: Sham

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trial to Evaluate UltraSound in the Treatment of Tibial Fractures

Resource links provided by NLM:


Further study details as provided by Bioventus LLC:

Primary Outcome Measures:
  • Change From Baseline in the SF-36 Physical Component Summary (PCS) Score of the Short Form-36 (SF-36) [ Time Frame: Over 365 days ] [ Designated as safety issue: No ]
    Assessments at baseline and 6 post baseline time points/ mixed effects repeated measure single point estimate. Range= -100 worst, 0 best

  • Time (Days) to Radiographic Healing of Tibial Fractures [ Time Frame: over 365 days ] [ Designated as safety issue: No ]
    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:
  • 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 501
Study Start Date: September 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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+

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667849

Locations
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
Principal Investigator: Mohit Bhandari, MD McMaster University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bioventus LLC
ClinicalTrials.gov Identifier: NCT00667849     History of Changes
Other Study ID Numbers: EX-TIB-0907 
Study First Received: April 21, 2008
Results First Received: September 24, 2015
Last Updated: November 4, 2015
Health Authority: United States: Food and Drug Administration
Canada: Canadian Institutes of Health Research

Keywords provided by Bioventus LLC:
Tibia

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 30, 2016