Tibial FracturesTRUSTNCT00667849

Trial to Evaluate UltraSound in the Treatment of Tibial Fractures

A study testing Exogen 4000+ in people with Tibial Fractures, run by Bioventus LLC at 16 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Tibial Fractures
What is being tested?: Exogen 4000+
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 501 participants
Where: 16 sitesin 2 countries
Study dates: Sep 2008to Dec 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

16 sites in 2 countries.

Country

City, postcode or hospital

16 sites in 2 countries

United States13 sites

Eastern Maine Medical Center
Bangor, Maine, 04401
University of Missouri
Columbia, Missouri, 65212
Duke University Medical Center
Durham, North Carolina, 27710
Orthopedic Specialtiy Associates
Fort Worth, Texas, 76104
Greenville Hospital System
Greenville, South Carolina, 29605
OrthoIndy
Indianapolis, Indiana, 46202
University of Kentucky
Lexington, Kentucky, 50436
West Virginia University
Morgantown, West Virginia, 26506
Insall Scott Kelly Institute
New York, New York, 10065
Rothman Institute
Philadelphia, Pennsylvania, 19107
Temple University Hospital
Philadelphia, Pennsylvania, 19140
San Francisco General/Dept of Orthopedic Surgery
San Francisco, California, 94110
Florida Orthopedic Institute
Tampa, Florida, 33606

Other trials in United States

Canada3 sites

Foothills Medical Centre
Calgary, Alberta, T2N 2T9
QE II Health Sciences Centre
Halifax, Nova Scotia
Vancouver Coastal Health
Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

About this study

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

Read the 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.

Conditions: Tibial Fractures
Being tested: Exogen 4000+, Sham
Keywords: Tibia
Medical subject headings: Tibial Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Exogen 4000+Device
Also called Exogen Bone Healing System - 4000+ series
Low-intensity pulsed ultrasound (LIPUS)
ShamDevice
Also called Single arm, sham of the Exogen 4000+
sham device identical to active device with the exception of administration of ultrasound

Study groups in NCT00667849
Study group	Role	What they receive
Exogen 4000+	Active comparator	Single arm, Exogen 4000+ Receives: Device: Exogen 4000+
Sham	Sham comparator	Single arm, sham (identical device with the exception of administration of ultrasound). Receives: Device: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: over 365 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008Dec 2012

First posted28 Apr 2008 (estimated)
Study startSep 2008
Primary completionDec 2012
Study completionDec 2012

Why it stopped: Study was terminated due to futility

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Tibial FracturesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 501 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00667849
Sponsor's protocol ID: EX-TIB-0907
Acronym: TRUST
Status last verified: Nov 2015
First submitted: 21 Apr 2008
Last updated: 8 Dec 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 33196584
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.
PubMed 27797787
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.
PubMed 24898987
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.
PubMed 22050862

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Tibial Fracture, Femoral Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
RecruitingPhase 3
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
Open tíbia Fracture
Not yet recruiting
Personalized Weight-Bearing With Smart Crutch Tips After Surgery for Tibial Plateau Fractures
Tibial Plateau Fracture
Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture

All Tibial Fractures trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Trial to Evaluate UltraSound in the Treatment of Tibial Fractures
ClinicalTrials.gov ID: NCT00667849
Acronym / sponsor ID: TRUST / EX-TIB-0907
Conditions: Tibial Fractures
Keywords: Tibia
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study was terminated due to futility
Enrolment: 501 participants (actual)
Lead sponsor: Bioventus LLCIndustry (pharma, biotech, devices)
Collaborators: McMaster University, Clinical Advances Through Research and Information Translation
Study start: Sep 2008
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 28 Apr 2008 (estimated)
Results: Posted 8 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Exogen 4000+	Active comparator	Device: Exogen 4000+Single arm, Exogen 4000+
Sham	Sham comparator	Device: ShamSingle arm, sham (identical device with the exception of administration of ultrasound).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Exogen 4000+Also: Exogen Bone Healing System - 4000+ seriesLow-intensity pulsed ultrasound (LIPUS)	Device	Exogen 4000+
ShamAlso: Single arm, sham of the Exogen 4000+sham device identical to active device with the exception of administration of ultrasound	Device	Sham

Primary outcome

Change From Baseline in the SF-36 Physical Component Summary (PCS) Score of the Short Form-36 (SF-36)
Time frame: Over 365 days
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
Time frame: over 365 days
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

Results and safety

Results posted to the registry on 8 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exogen 4000+	250	142
Sham	251	130

Primary outcome: Change From Baseline in the SF-36 Physical Component Summary (PCS) Score of the Short Form-36 (SF-36)

Time frame: Over 365 days. Least squares mean (95% Confidence Interval). Unit: units on a scale

Measure	Exogen 4000+ n = 241	Sham n = 242
Value	-6.9 (-8.0 to -5.9)	-7.5 (-8.6 to -6.5)

Population analysed: Full Analysis Set (FAS) is all subjects randomized with at least one post treatment set of adjudicated x-rays.

Primary outcome: Time (Days) to Radiographic Healing of Tibial Fractures

Time frame: over 365 days. Median (Inter-Quartile Range). Unit: days

Measure	Exogen 4000+ n = 241	Sham n = 242
Value	130 (112 to 183)	133 (115 to 186)

Population analysed: Full Analysis Set (FAS) is all subjects randomized with at least one post treatment set of adjudicated x-rays.

Adverse events

Time frame: up to 2 years. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exogen 4000+	3 of 250 (1.2%)	98 of 250 (39.2%)	Not reported
Sham	5 of 251 (2%)	97 of 251 (38.6%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33196584Findakli 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.
Derived from this study: PubMed 27797787TRUST 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.
Derived from this study: PubMed 24898987Busse 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.
Derived from this study: PubMed 22050862Dijkman 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.

Related trials for Tibial Fractures

Not yet recruiting
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Tibial Fracture, Femoral Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
RecruitingPhase 3
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
Open tíbia Fracture
Not yet recruiting
Personalized Weight-Bearing With Smart Crutch Tips After Surgery for Tibial Plateau Fractures
Tibial Plateau Fracture
Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mohit Bhandari, MD principal investigator

McMaster University

16 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Exogen 4000+ in people with Tibial Fractures, run by Bioventus LLC at 16 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the SF-36 Physical Component Summary (PCS) Score of the Short Form-36 (SF-36) (time frame: Over 365 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00667849, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2015.