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A randomized controlled trial evaluating the effects of intra-operative CT on the outcomes of zygomatic fractures.

A randomized controlled trial evaluating the effects of intra-operative CT on the outcomes of zygomatic fractures.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000693426
Enrollment
186
Registered
2016-05-26
Start date
2016-07-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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-operativ

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.

Sponsors

Royal Brisbane and Women's Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

fracture of the zygomaticomaxillary complex requiring surgical intervention

Exclusion criteria

active pregnancy

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 2, 2026