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
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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 Bone Healing System |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: 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 Smith & Nephew, Inc.:
Primary Outcome Measures:
- Radiographs [ Time Frame: 6, 12, 18, 26, 38 and 52 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Rates of nonunion of tibial fractures [ Time Frame: 6, 12, 18, 26, 38 and 52 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Active ultrasound bone healing units versus inactive ultrasound units
|
Device: Exogen Bone Healing System
Low intensity pulsed ultrasound
Other Name: Exogen Bone Healing System
|
| Sham Comparator: 2 |
Device: Exogen Bone Healing System
Low intensity pulsed ultrasound
Other Name: Exogen Bone Healing System
|
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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00667849
Contacts
| Contact: Brett Gordon, BS | 919-474-6747 | brett.gordon@smith-nephew.com |
| Contact: Edward Philpot, M.D. | 919-474-6777 | edward.philpot@smith-nephew.com |
Locations
| United States, California | |
| San Francisco General/Dept of Orthopedic Surgery | Recruiting |
| San Francisco, California, United States, 94110 | |
| Principal Investigator: Theodore Miclau, MD | |
| United States, Florida | |
| Florida Orthopedic Institute | Recruiting |
| Tampa, Florida, United States, 33606 | |
| Principal Investigator: Claude Sagi, MD | |
| United States, Indiana | |
| OrthoIndy | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Principal Investigator: Dean Maar, MD | |
| United States, Kentucky | |
| University of Kentucky | Recruiting |
| Lexington, Kentucky, United States, 50436 | |
| Principal Investigator: Jeffrey Selby, MD | |
| United States, Maine | |
| Eastern Maine Medical Center | Recruiting |
| Bangor, Maine, United States, 04401 | |
| Principal Investigator: David Carmack, MD | |
| United States, Missouri | |
| University of Missouri | Recruiting |
| Columbia, Missouri, United States, 65212 | |
| Principal Investigator: Gregory Della Rocca, MD | |
| United States, New York | |
| Insall Scott Kelly Institute | Recruiting |
| New York, New York, United States, 10065 | |
| Principal Investigator: Craig Radnay, MD | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: Robert Zura, MD | |
| United States, Pennsylvania | |
| Temple University Hospital | Recruiting |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Principal Investigator: Saqib Rehman, MD | |
| Rothman Institute | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Principal Investigator: Javad Parvizi, MD | |
| United States, South Carolina | |
| Greenville Hospital System | Recruiting |
| Greenville, South Carolina, United States, 29605 | |
| Principal Investigator: Kyle Jeray, MD | |
| United States, Texas | |
| Orthopedic Specialtiy Associates | Recruiting |
| Fort Worth, Texas, United States, 76104 | |
| Principal Investigator: Cory Collinge, MD | |
| United States, West Virginia | |
| West Virginia University | Recruiting |
| Morgantown, West Virginia, United States, 26506 | |
| Principal Investigator: Franklin Shuler, MD | |
| Canada, Alberta | |
| Foothills Medical Centre | Recruiting |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Principal Investigator: Paul Duffy, MD | |
| Canada, British Columbia | |
| Vancouver Coastal Health | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Principal Investigator: Peter O'Brien, MD | |
| Canada, Nova Scotia | |
| QE II Health Sciences Centre | Recruiting |
| Halifax, Nova Scotia, Canada | |
| Principal Investigator: Chad Coles, MD | |
Sponsors and Collaborators
Smith & Nephew, Inc.
Canadian Institutes of Health Research (CIHR)
Investigators
| Principal Investigator: | Mohit Bhandari, MD | McMaster University |
More Information
No publications provided by Smith & Nephew, Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Becky Fortner / Manager,Clinical Affairs, Smith & Nephew, Inc. |
| ClinicalTrials.gov Identifier: | NCT00667849 History of Changes |
| Other Study ID Numbers: | EX-TIB-0907 |
| Study First Received: | April 21, 2008 |
| Last Updated: | April 21, 2011 |
| Health Authority: | United States: Food and Drug Administration Canada: Canadian Institutes of Health Research |
Keywords provided by Smith & Nephew, Inc.:
|
Tibia |
Additional relevant MeSH terms:
|
Fractures, Bone Tibial Fractures Wounds and Injuries Leg Injuries |
ClinicalTrials.gov processed this record on May 21, 2013