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Trial registered on ANZCTR


Registration number
ACTRN12616000693426
Ethics application status
Approved
Date submitted
23/05/2016
Date registered
26/05/2016
Date last updated
26/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized controlled trial evaluating the effects of intra-operative CT on the outcomes of zygomatic fractures.
Scientific title
A randomized controlled trial evaluating the effects of intra-operative CT on the outcomes of zygomatic fractures.
Secondary ID [1] 289277 0
None
Universal Trial Number (UTN)
U1111-1183-1194
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fractured zygomaticomaxillary complex 298863 0
Condition category
Condition code
Surgery 298930 298930 0 0
Other surgery
Injuries and Accidents 298952 298952 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
intra-operative computed tomography imaging:

the current standard of care for patients with zygomaticomaxillary complex fractures is surgery, followed by post-operative plain film xrays. This current standard of care will be maintained as the "control group".
The intervention arm will receive the same treatment (surgery, followed by post-operative plain film xrays), except that the participants will ALSO receive intra-operative imaging in the form of CT scanning of the face. The intra-operative CT scanning will be utilised after reduction and fixation of the fracture. The CT machine will be wheeled into the operating theatre by a hospital radiographer, and a CT scan will be taken of the relevant anatomy by the radiographer as per the hospital's standard protocols for intra-operative CT imaging. It is hoped that intra-operative CT will allow for identification of non-ideal treatments before the patient is extubated and taken from theatre, allowing for rectification during the same theatre session.
Intervention code [1] 294826 0
Treatment: Surgery
Intervention code [2] 294843 0
Treatment: Other
Comparator / control treatment
post-operative plain film imaging after the patient leaves the recovery suites - this may be done on the same day as the surgery, or on the following day, prior to discharge.
Control group
Active

Outcomes
Primary outcome [1] 298401 0
Need for revision surgery - assessed by review of medical records.
Timepoint [1] 298401 0
immediately, 1 week and 6 weeks post operative
Secondary outcome [1] 324024 0
Post-operative radiographic reduction adequacy - assessed by review of medical records (post-operative plain films).
Such outcomes will be assessed in a blinded manner by a consultant oral and maxillofacial surgeon. outcomes will be as such:
1. good
2. fair
3. poor
Timepoint [1] 324024 0
post-operative

Eligibility
Key inclusion criteria
fracture of the zygomaticomaxillary complex requiring surgical intervention
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
active pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation - 100 sealed letters with "control" and 100 sealed letters with "intervention" within will be inserted into a box.
A nurse not involved in the research project will be asked to randomly draw out a letter for each participant.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
186
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5835 0
Royal Brisbane & Womens Hospital - Herston

Funding & Sponsors
Funding source category [1] 293655 0
Hospital
Name [1] 293655 0
Royal Brisbane and Women's Hospital
Country [1] 293655 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
RBWH
Butterfield St
HERSTON
QLD 4029
Australia
Country
Australia
Secondary sponsor category [1] 292491 0
None
Name [1] 292491 0
Address [1] 292491 0
Country [1] 292491 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295092 0
RBWH HREC
Ethics committee address [1] 295092 0
Human Research Ethics Office
Royal Brisbane and Women's Hospital
Level 7, Block 7
Butterfield Street
Herston, Qld, 4029
Ethics committee country [1] 295092 0
Australia
Date submitted for ethics approval [1] 295092 0
Approval date [1] 295092 0
28/04/2016
Ethics approval number [1] 295092 0

Summary
Brief summary
Patients with fractures of the cheekbone and related structures often require surgery to restore the profile and function of the face. This usually requires access to the fractures by small incisions around the eye and in the mouth. The fractured segments are not routinely completely exposed and visualized, so as to minimize scarring and trauma to other vital structures such as nerves and blood vessels. The fractures are reduced (to their correct position) by feel, through limited visualization through the small incisions, and by assessment of the facial profile. Once reduced, the fractures are fixed in place with metal plates and screws through the small access incisions. Radiographic information is required post-operatively in the form of multiple plain films or a CT scan of the face, to ensure appropriate reduction of the fracture segments. Owing to the difficulty in assessing fracture reduction through small incisions in an otherwise swollen and traumatized face, it has been suggested that the gold standard in the management of such fractures should be intra-operative, rather than post-operative CT. It has been proposed that intra-operative CT imaging would eliminate the need for revision surgery due to inadequate fracture reduction, and would improve other outcomes of surgery such as facial profile restoration and scar minimization. It should be noted that other surgical specialties, in particular Orthopaedics, rely heavily on intra-operative imaging modalities.
In the proposed RCT, patients would be randomized to an intervention group and a control group. The intervention group would receive intra-operative CT scanning in addition to post-operative plain film post-operative scanning. The scanning would occur after initial fixation of fracture segments to confirm fracture reduction adequacy. If re-reduction were required, further intra-operative imaging would be utilized following each successive reduction attempt, thus allowing for rectification under the same general anaesthetic and eliminating the need to either return to theatre at a later date, or to accept a sub-optimal outcome. The control group would receive post-operative plain film imaging as per the current clinical policy.
Participants would not be required to make any commitments additional to what is required of them as a patient of the Unit. Participants from both the intervention and control groups would undergo routine post-operative review, as for non-trial patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66102 0
Dr Michael Hurrell
Address 66102 0
RBWH
Butterfield St
HERSTON
QLD 4029
Australia
Country 66102 0
Australia
Phone 66102 0
+61400034155
Fax 66102 0
Email 66102 0
michael.hurrell@uqconnect.edu.au
Contact person for public queries
Name 66103 0
Dr Michael Hurrell
Address 66103 0
RBWH
Butterfield St
HERSTON
QLD 4029
Australia
Country 66103 0
Australia
Phone 66103 0
+61400034155
Fax 66103 0
Email 66103 0
michael.hurrell@uqconnect.edu.au
Contact person for scientific queries
Name 66104 0
Dr Michael Hurrell
Address 66104 0
RBWH
Butterfield St
HERSTON
QLD 4029
Australia
Country 66104 0
Australia
Phone 66104 0
+61400034155
Fax 66104 0
Email 66104 0
michael.hurrell@uqconnect.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA study protocol for a randomised controlled trial evaluating the effects of intraoperative computed tomography on the outcomes of zygomatic fractures.2019https://dx.doi.org/10.1186/s13063-019-3625-8
N.B. These documents automatically identified may not have been verified by the study sponsor.