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.
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.
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
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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Bioventus LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- McMaster University, Clinical Advances Through Research and Information Translation
- Responsible party
- Sponsor
- Investigators
- Mohit Bhandari, MD, Principal investigator, McMaster University
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 33196584TRUST 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 27797787Busse 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 24898987Dijkman 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
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
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.
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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; AzTrials last refreshed its copy on 8 Nov 2026.