TRial to Evaluate UltraSound in the Treatment of Tibial Fractures (TRUST)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Smith & Nephew, Inc..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Smith & Nephew, Inc.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
Smith & Nephew, Inc.
ClinicalTrials.gov Identifier:
NCT00667849
First received: April 21, 2008
Last updated: April 21, 2011
Last verified: October 2010
| Tracking Information | |||||||||
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| First Received Date ICMJE | April 21, 2008 | ||||||||
| Last Updated Date | April 21, 2011 | ||||||||
| Start Date ICMJE | September 2008 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Radiographs [ Time Frame: 6, 12, 18, 26, 38 and 52 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00667849 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Rates of nonunion of tibial fractures [ Time Frame: 6, 12, 18, 26, 38 and 52 ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | TRial to Evaluate UltraSound in the Treatment of Tibial Fractures | ||||||||
| Official Title ICMJE | TRial to Evaluate UltraSound in the Treatment of Tibial Fractures | ||||||||
| Brief Summary | The purpose of this study is to determine the effect of low-intensity, pulsed ultrasound on tibial fractures treated with intramedullary nailing. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Tibial Fractures | ||||||||
| Intervention ICMJE | Device: Exogen Bone Healing System
Low intensity pulsed ultrasound
Other Name: Exogen Bone Healing System |
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| Study Arm (s) |
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| Publications * | 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 500 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States, Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00667849 | ||||||||
| Other Study ID Numbers ICMJE | EX-TIB-0907 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Becky Fortner / Manager,Clinical Affairs, Smith & Nephew, Inc. | ||||||||
| Study Sponsor ICMJE | Smith & Nephew, Inc. | ||||||||
| Collaborators ICMJE | Canadian Institutes of Health Research (CIHR) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Smith & Nephew, Inc. | ||||||||
| Verification Date | October 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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