ANZCTR - Registration

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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]

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

Condition category

Condition code

Surgery

Other surgery

Injuries and Accidents

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]

Treatment: Surgery

Intervention code [2]

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]

Need for revision surgery - assessed by review of medical records.

Timepoint [1]

immediately, 1 week and 6 weeks post operative

Secondary outcome [1]

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]

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?

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]

Royal Brisbane & Womens Hospital - Herston

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Brisbane and Women's Hospital

Address [1]

RBWH
Butterfield St
HERSTON
QLD 4029
Australia

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

RBWH HREC

Ethics committee address [1]

Human Research Ethics Office
Royal Brisbane and Women's Hospital
Level 7, Block 7
Butterfield Street
Herston, Qld, 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

28/04/2016

Ethics approval number [1]

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

Dr Michael Hurrell

Address

RBWH
Butterfield St
HERSTON
QLD 4029
Australia

Country

Australia

Phone

+61400034155

Fax

[email protected]

Contact person for public queries

Name

Michael Hurrell

Address

RBWH
Butterfield St
HERSTON
QLD 4029
Australia

Country

Australia

Phone

+61400034155

Fax

[email protected]

Contact person for scientific queries

Name

Michael Hurrell

Address

RBWH
Butterfield St
HERSTON
QLD 4029
Australia

Country

Australia

Phone

+61400034155

Fax

[email protected]

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

Source	Title	Year of Publication	DOI
Embase	A study protocol for a randomised controlled trial evaluating the effects of intraoperative computed tomography on the outcomes of zygomatic fractures.	2019	https://dx.doi.org/10.1186/s13063-019-3625-8

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically