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

April 21, 2008
November 4, 2015
September 2008
December 2012   (final data collection date for primary outcome measure)
  • 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
Radiographs [ Time Frame: 6, 12, 18, 26, 38 and 52 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00667849 on ClinicalTrials.gov Archive Site
Not Provided
Rates of nonunion of tibial fractures [ Time Frame: 6, 12, 18, 26, 38 and 52 ] [ Designated as safety issue: No ]
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.
Not Provided
 
Trial to Evaluate UltraSound in the Treatment of Tibial Fractures
Trial to Evaluate UltraSound in the Treatment of Tibial Fractures
The purpose of this study is to determine the effect of low-intensity, pulsed ultrasound on tibial fractures treated with intramedullary nailing.
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Tibial Fractures
  • Device: Exogen 4000+
    Low-intensity pulsed ultrasound (LIPUS)
    Other Name: Exogen Bone Healing System - 4000+ series
  • Device: Sham
    sham device identical to active device with the exception of administration of ultrasound
    Other Name: Single arm, sham of the Exogen 4000+
  • Active Comparator: Exogen 4000+
    Single arm, Exogen 4000+
    Intervention: Device: Exogen 4000+
  • Sham Comparator: Sham
    Single arm, sham (identical device with the exception of administration of ultrasound).
    Intervention: Device: Sham

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
501
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00667849
EX-TIB-0907
Yes
Not Provided
Not Provided
Bioventus LLC
Bioventus LLC
  • McMaster University
  • Clinical Advances Through Research and Information Translation
Principal Investigator: Mohit Bhandari, MD McMaster University
Bioventus LLC
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP