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

This study has been terminated.
(Study was terminated due to futility)
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Bioventus LLC
ClinicalTrials.gov Identifier:
NCT00667849
First received: April 21, 2008
Last updated: March 17, 2015
Last verified: March 2015

April 21, 2008
March 17, 2015
September 2008
December 2012   (final data collection date for primary outcome measure)
Radiographs [ Time Frame: 6, 12, 18, 26, 38 and 52 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00667849 on ClinicalTrials.gov Archive Site
Rates of nonunion of tibial fractures [ Time Frame: 6, 12, 18, 26, 38 and 52 ] [ Designated as safety issue: No ]
Same as current
Not Provided
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-treatment 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: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Tibial Fractures
  • Device: Exogen 4000 + active device
    Low-intensity pulsed ultrasound (LIPUS)
    Other Name: Exogen Bone Healing System
  • Device: Exogen 4000 + sham device
    sham device identical to active device with the exception of administration of ultrasound
    Other Name: Single arm, sham Exogen 4000+ bone healing system
  • Active Comparator: Exogen 4000 + active device
    Single arm, active Exogen 4000+ ultrasound bone healing system
    Intervention: Device: Exogen 4000 + active device
  • Sham Comparator: Exogen 4000+ sham device
    Single arm, sham (identical to active device with the exception of administration of ultrasound) Exogen 4000+ bone healing system.
    Intervention: Device: Exogen 4000 + sham device

*   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
Bioventus LLC
Bioventus LLC
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Mohit Bhandari, MD McMaster University
Bioventus LLC
March 2015

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