Trial to Evaluate UltraSound in the Treatment of Tibial Fractures

Tibial Fractures Clinical Trial

— TRUST  

Official title:

Trial to Evaluate UltraSound in the Treatment of Tibial Fractures

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00667849
• Other study ID #: EX-TIB-0907
• Status: Terminated
• Phase: N/A
• First received: April 21, 2008
• Last updated: November 4, 2015
• Start date: September 2008
• Est. completion date: December 2012

Study information

• Verified date: November 2015
• Source: Bioventus LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect of low-intensity, pulsed ultrasound on tibial fractures treated with intramedullary nailing.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 501
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Tibial Fractures

Intervention

Device:
• Exogen 4000+
Low-intensity pulsed ultrasound (LIPUS)
• Sham
sham device identical to active device with the exception of administration of ultrasound

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	QE II Health Sciences Centre	Halifax	Nova Scotia
Canada	Vancouver Coastal Health	Vancouver	British Columbia
United States	Eastern Maine Medical Center	Bangor	Maine
United States	University of Missouri	Columbia	Missouri
United States	Duke University Medical Center	Durham	North Carolina
United States	Orthopedic Specialtiy Associates	Fort Worth	Texas
United States	Greenville Hospital System	Greenville	South Carolina
United States	OrthoIndy	Indianapolis	Indiana
United States	University of Kentucky	Lexington	Kentucky
United States	West Virginia University	Morgantown	West Virginia
United States	Insall Scott Kelly Institute	New York	New York
United States	Rothman Institute	Philadelphia	Pennsylvania
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	San Francisco General/Dept of Orthopedic Surgery	San Francisco	California
United States	Florida Orthopedic Institute	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Bioventus LLC	Clinical Advances Through Research and Information Translation, McMaster University

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Compliance	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.	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)	No
Primary	Change From Baseline in the SF-36 Physical Component Summary (PCS) Score of the Short Form-36 (SF-36)	Assessments at baseline and 6 post baseline time points/ mixed effects repeated measure single point estimate. Range= -100 worst, 0 best	Over 365 days	No
Primary	Time (Days) to Radiographic Healing of Tibial Fractures	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	over 365 days	No