Brief Summary

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

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

501

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Sep 2008

Longer than P75 for not_applicable

Geographic Reach

2 countries

16 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.3 years study duration

First Submitted

Initial submission to the registry

April 21, 2008

Completed

7 days until next milestone

First Posted

Study publicly available on registry

April 28, 2008

Completed

4 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed

4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed

3 years until next milestone

Results Posted

Study results publicly available

December 8, 2015

Completed

Last Updated

December 8, 2015

Status Verified

November 1, 2015

Enrollment Period

4.3 years

First QC Date

April 21, 2008

Results QC Date

September 24, 2015

Last Update Submit

November 4, 2015

Conditions

Tibial Fractures

Keywords

Tibia

Outcome Measures

Primary Outcomes (2)

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
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

Other Outcomes (1)

Treatment Compliance
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)

Study Arms (2)

Exogen 4000+

ACTIVE COMPARATOR

Single arm, Exogen 4000+

Device: Exogen 4000+

Sham

SHAM COMPARATOR

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

Device: Sham

Interventions

Exogen 4000+DEVICE

Low-intensity pulsed ultrasound (LIPUS)

Also known as: Exogen Bone Healing System - 4000+ series

Exogen 4000+

ShamDEVICE

sham device identical to active device with the exception of administration of ultrasound

Also known as: Single arm, sham of the Exogen 4000+

Sham

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Males and females age 18 years or older
Have an open or closed tibial fracture amenable to intramedullary nail fixation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Bioventus LLClead
McMaster Universitycollaborator
Clinical Advances Through Research and Information Translationcollaborator

Study Sites (16)

San Francisco General/Dept of Orthopedic Surgery

San Francisco, California, 94110, United States

Location

Florida Orthopedic Institute

Tampa, Florida, 33606, United States

Location

OrthoIndy

Indianapolis, Indiana, 46202, United States

Location

University of Kentucky

Lexington, Kentucky, 50436, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

Insall Scott Kelly Institute

New York, New York, 10065, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

Orthopedic Specialtiy Associates

Fort Worth, Texas, 76104, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Vancouver Coastal Health

Vancouver, British Columbia, V5Z 1M9, Canada

Location

QE II Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

Related Publications (4)

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.
PMID: 33196584DERIVED
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.
PMID: 27797787DERIVED
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.
PMID: 24898987DERIVED
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.
PMID: 22050862DERIVED

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Limitations and Caveats

Poor Compliance: Protocol defined compliance as ≥18 minutes use per day. Devices have a treatment monitor that showed average compliance of 42.3% (sham) and 44.6% (active) in 80% of treatment days. Poor treatment adherence confounds results.

Results Point of Contact

Title: Peter Heeckt, MD (CMO)
Organization: Bioventus LLC

Study Officials

Mohit Bhandari, MD
McMaster University
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: LTE60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 21, 2008

First Posted

April 28, 2008

Study Start

September 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 8, 2015

Results First Posted

December 8, 2015

Record last verified: 2015-11

Locations

US(13)CA(3)

Study Stopped

Trial to Evaluate UltraSound in the Treatment of Tibial Fractures

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Other Outcomes (1)

Study Arms (2)

Exogen 4000+

Sham

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (16)

Related Publications (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Other Outcomes (1)

Study Arms (2)

Exogen 4000+

Sham

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (16)

Related Publications (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations