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

Primary Purpose

Tibial Fractures

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Exogen 4000+
Sham
Sponsored by
Bioventus LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tibial Fractures focused on measuring Tibia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • San Francisco General/Dept of Orthopedic Surgery
  • Florida Orthopedic Institute
  • OrthoIndy
  • University of Kentucky
  • Eastern Maine Medical Center
  • University of Missouri
  • Insall Scott Kelly Institute
  • Duke University Medical Center
  • Rothman Institute
  • Temple University Hospital
  • Greenville Hospital System
  • Orthopedic Specialtiy Associates
  • West Virginia University
  • Foothills Medical Centre
  • Vancouver Coastal Health
  • QE II Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Exogen 4000+

Sham

Arm Description

Single arm, Exogen 4000+

Single arm, sham (identical device with the exception of administration of ultrasound).

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
April 21, 2008
Last Updated
November 4, 2015
Sponsor
Bioventus LLC
Collaborators
McMaster University, Clinical Advances Through Research and Information Translation
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1. Study Identification

Unique Protocol Identification Number
NCT00667849
Brief Title
Trial to Evaluate UltraSound in the Treatment of Tibial Fractures
Acronym
TRUST
Official Title
Trial to Evaluate UltraSound in the Treatment of Tibial Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated due to futility
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioventus LLC
Collaborators
McMaster University, Clinical Advances Through Research and Information Translation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fractures
Keywords
Tibia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
501 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exogen 4000+
Arm Type
Active Comparator
Arm Description
Single arm, Exogen 4000+
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Single arm, sham (identical device with the exception of administration of ultrasound).
Intervention Type
Device
Intervention Name(s)
Exogen 4000+
Other Intervention Name(s)
Exogen Bone Healing System - 4000+ series
Intervention Description
Low-intensity pulsed ultrasound (LIPUS)
Intervention Type
Device
Intervention Name(s)
Sham
Other Intervention Name(s)
Single arm, sham of the Exogen 4000+
Intervention Description
sham device identical to active device with the exception of administration of ultrasound
Primary Outcome Measure Information:
Title
Change From Baseline in the SF-36 Physical Component Summary (PCS) Score of the Short Form-36 (SF-36)
Description
Assessments at baseline and 6 post baseline time points/ mixed effects repeated measure single point estimate. Range= -100 worst, 0 best
Time Frame
Over 365 days
Title
Time (Days) to Radiographic Healing of Tibial Fractures
Description
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
Time Frame
over 365 days
Other Pre-specified Outcome Measures:
Title
Treatment Compliance
Description
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.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohit Bhandari, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco General/Dept of Orthopedic Surgery
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Florida Orthopedic Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
OrthoIndy
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
50436
Country
United States
Facility Name
Eastern Maine Medical Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Insall Scott Kelly Institute
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Greenville Hospital System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Orthopedic Specialtiy Associates
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Vancouver Coastal Health
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
QE II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
33196584
Citation
Findakli F, Busse JW, Schemitsch EH, Lonn E, Farrokhyar F, Bhandari M; and the TRUST Investigators. Smoking, Obesity, and Disability Benefits or Litigation Are Not Associated with Clinically Important Reductions in Physical Functioning After Intramedullary Nailing of Tibial Shaft Fractures: A Retrospective Cohort Study. Clin Orthop Relat Res. 2021 Apr 1;479(4):805-813. doi: 10.1097/CORR.0000000000001573.
Results Reference
derived
PubMed Identifier
27797787
Citation
TRUST Investigators writing group; Busse JW, Bhandari M, Einhorn TA, Schemitsch E, Heckman JD, Tornetta P 3rd, Leung KS, Heels-Ansdell D, Makosso-Kallyth S, Della Rocca GJ, Jones CB, Guyatt GH. Re-evaluation of low intensity pulsed ultrasound in treatment of tibial fractures (TRUST): randomized clinical trial. BMJ. 2016 Oct 25;355:i5351. doi: 10.1136/bmj.i5351.
Results Reference
derived
PubMed Identifier
24898987
Citation
Busse JW, Bhandari M, Einhorn TA, Heckman JD, Leung KS, Schemitsch E, Tornetta P 3rd, Walter SD, Guyatt GH. Trial to re-evaluate ultrasound in the treatment of tibial fractures (TRUST): a multicenter randomized pilot study. Trials. 2014 Jun 4;15:206. doi: 10.1186/1745-6215-15-206.
Results Reference
derived
PubMed Identifier
22050862
Citation
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.
Results Reference
derived

Learn more about this trial

Trial to Evaluate UltraSound in the Treatment of Tibial Fractures

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