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: July 23, 2013
Last verified: July 2013

April 21, 2008
July 23, 2013
September 2008
March 2013   (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 Bone Healing System
Low intensity pulsed ultrasound
Other Name: Exogen Bone Healing System
  • Active Comparator: 1
    Active ultrasound bone healing units versus inactive ultrasound units
    Intervention: Device: Exogen Bone Healing System
  • Sham Comparator: 2
    Intervention: Device: Exogen Bone Healing System
Dijkman BG, Busse JW, Walter SD, Bhandari M; TRUST Investigators. The impact of clinical data on the evaluation of tibial fracture healing. Trials. 2011 Nov 3;12:237. doi: 10.1186/1745-6215-12-237.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
501
March 2013
March 2013   (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
July 2013

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