Condition category
Injury, Occupational Diseases, Poisoning
Date applied
09/09/2005
Date assigned
09/09/2005
Last edited
06/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.mcmaster.ca/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes