Contact information
Type
Scientific
Primary contact
Dr Gordon Henry Guyatt
ORCID ID
Contact details
McMaster University
Clinical Epidemiology & Biostatistics
Health Sciences Centre
Room 2C12
1200 Main Street West
Hamilton
L8N 3Z5
Canada
+1 905 525 9140 ext. 22900
guyatt@mcmaster.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-67815
Study information
Scientific title
Re-evaluating ultrasound in the treatment of tibial fractures: a randomised controlled trial
Acronym
TRUST
Study hypothesis
That the UltraSound Treatment will significantly reduce the time it takes to return to functionality
Ethics approval
McMaster University Research Ethics Board approved on the 14th May 2004
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Tibial shaft fractures
Intervention
After they agree to participate in the study and have provided informed consent, and as close in time to the reduction and casing as possible, the patients will be randomised to receive either an active or a placebo ultrasound device. In order to ensure a standardised signal, each patient will use a newly calibrated Sonic Accelerated Fracture Healing System (SAFHS 2A) manufactured by Exogen (Piscataway, New Jersey). Smith & Nephew have donated all ultrasound units required for this trial. Neither the patient or the clinician will be able to adjust the ultrasound signal. To ensure reliable positioning of the SAFHS 2A unit during treatment the surgeon will insert a retaining and alignment fixture made of molded plastic into a window centered over the anteromedial surface of the cast at the site of the tibial fracture. This fixture will hold the treatment head module in place during the daily 20-minute treatment period, thus ensuring that the patient can effectively administer the treatment. After removal of the felt plug and following the application of a small amount of ultrasonic coupling gel (approximately 5 ml) to the surface of the ultrasound head, the patient will position the treatment head module in the window. The main operating unit emits a warning signal if there is not proper coupling to the skin. In addition, the main operating unit contains an integral timer that monitors treatment times and automatically turns the unit off after twenty minutes. A visual and audible signal serves to alert the patient that treatment is complete. The active and placebo devices are identical in every way, in that they have the same visual, tactile, and auditory signals except for the ultrasound signal emitted.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Physical summary score of the 36-item short form health survey (SF-36)
Secondary outcome measures
1. Time to radiographic healing of tibial fractures
2. Rates of malunion and non-union of tibial fractures
3. Rates of secondary procedures (operative and non-operative)
Overall trial start date
01/07/2005
Overall trial end date
31/01/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Men or women age over 18 years
2. Fracture of the tibial shaft with complete anterioposterior and lateral radiographs
3. Closed or grade I open tibial shaft fracture amenable to non-operative treatment (less than 1.5 cm of shortening, axially stable transverse fractures, spiral oblique of comminuted fractures with less than 12 mm of initial shortening; angulations less than 5° initially; less than 50% displacement)
4. Provision of informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. State that they cannot comply with the study protocol
2. Have pathological fractures or fractures that are to be treated operatively (comminuted fractures; unstable fracture patterns; tibial shaft shortening greater than 1.5 cm)
3. Likely problems, in the judgment of the investigators, with maintaining follow-up (such as no fixed address, plan to move out of town in the next year)
Recruitment start date
01/07/2005
Recruitment end date
31/01/2007
Locations
Countries of recruitment
Canada
Trial participating centre
McMaster University
Hamilton
L8N 3Z5
Canada
Sponsor information
Organisation
McMaster University (Canada)
Sponsor details
1200 Main Street West
Hamilton
L8N 3Z5
Canada
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-67815)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list