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Trial registered on ANZCTR


Registration number
ACTRN12621001069842p
Ethics application status
Submitted, not yet approved
Date submitted
31/05/2021
Date registered
13/08/2021
Date last updated
13/08/2021
Date data sharing statement initially provided
13/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of two implant materials for repair of orbital defects in patients with isolated orbital floor fractures.
Scientific title
Comparison of Titanium Plates with Titanium-Reinforced Polyethylene for the Reconstruction of Orbital Floor Defects: A Randomised Controlled Trial
Secondary ID [1] 304692 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Orbital floor fractures 322152 0
Condition category
Condition code
Surgery 319845 319845 0 0
Other surgery
Injuries and Accidents 320291 320291 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients requiring reconstruction of an orbital floor defect following trauma will be treated with either a conventional titanium implant or titanium-reinforced porous polyethylene. These patients will not be treated any different from routine clinical care. The care will be delivered by experienced Oral and Maxillofacial Surgeons to individuals. The intervention will only be surgically carried out once unless there is a need for revision surgery (e.g. infection). Titanium-reinforced porous polyethylene is a composite of the two most common materials used for orbital reconstruction - porous polyethylene and titanium. It aims to combine the desirable properties of the two constituent materials whilst mitigating their respective disadvantages. Both porous polyethylene and titanium have been available for orbital implantation for > 3 decades. The approximate duration of each surgery is expected to be 90 minutes.
Intervention code [1] 320728 0
Treatment: Surgery
Intervention code [2] 321068 0
Treatment: Devices
Comparator / control treatment
Conventional titanium implants (most commonly used material for orbital reconstruction) will be the control group. This surgery will only be performed once and is part of routine clinical care.
Control group
Active

Outcomes
Primary outcome [1] 327715 0
Magnitude of subjective diplopia following surgical reconstruction of an orbital floor defect using titanium or titanium-reinforced porous polyethylene. To be tested using a validated diplopia questionnaire by Holmes et al (2005).
Timepoint [1] 327715 0
Pre-operative (baseline), one month and three months post-operatively (primary endpoint)
Primary outcome [2] 327716 0
Presence of enophthalmos following orbital reconstruction with titanium or titanium-reinforced porous polyethylene. To be assessed using Hertel's exophthalmometer.
Timepoint [2] 327716 0
Pre-operative (baseline), one month and three months post-operatively (primary endpoint)
Primary outcome [3] 328144 0
Magnitude of objective diplopia following surgical reconstruction of an orbital floor defect using titanium or titanium-reinforced porous polyethylene. To be tested using a Hess chart.
Timepoint [3] 328144 0
Pre-operative (baseline), one month and three months post-operatively (primary endpoint)
Secondary outcome [1] 396323 0
Subjective ease of material handling between titanium and titanium-reinforced porous polyethylene. To be tested using a Likert scale (1 easiest - 5 most difficult)
Timepoint [1] 396323 0
Immediately post-operatively
Secondary outcome [2] 398645 0
Magnitude of enophthalmos following orbital reconstruction with titanium or titanium-reinforced porous polyethylene. To be assessed using Hertel's exophthalmometer (assessed as primary outcome).
Timepoint [2] 398645 0
Pre-operative (baseline), one month and three months post-operatively (primary endpoint)

Eligibility
Key inclusion criteria
Inclusion criteria consists of adults (> 18 years) with CT-proven orbital floor fractures (1) exceeding 50% or 1 cm3 of the orbital floor, (2) enophthalmos greater than 2.0 mm, (3) diplopia at any level of gaze, (4) any restriction of ocular motility.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria includes patients with orbital fractures involving walls other than the orbital floor, bilateral orbital trauma, endocrine orbitopathy, anophthalmia, uni- or bilateral loss of vision, defects caused by pathological lesions, craniofacial malformations, past radiation or chemotherapy to the orbits, cognitive impairment or lack of interaction with the surgical team post-operatively.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/08/2021
Actual
Date of last participant enrolment
Anticipated
15/08/2022
Actual
Date of last data collection
Anticipated
24/10/2022
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 23743 0
New Zealand
State/province [1] 23743 0

Funding & Sponsors
Funding source category [1] 308739 0
Hospital
Name [1] 308739 0
Counties Manukau DHB - Middlemore Hospital
Country [1] 308739 0
New Zealand
Primary sponsor type
Government body
Name
Counties Manukau DHB
Address
100 Hospital Road
Middlemore Hospital
Auckland 2025
Country
New Zealand
Secondary sponsor category [1] 309634 0
Government body
Name [1] 309634 0
Auckland DHB
Address [1] 309634 0
2 Park Road
Grafton
Auckland 1023
Country [1] 309634 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308659 0
Health and Disability Ethics Committees (HDECs)
Ethics committee address [1] 308659 0
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 308659 0
New Zealand
Date submitted for ethics approval [1] 308659 0
01/06/2021
Approval date [1] 308659 0
Ethics approval number [1] 308659 0

Summary
Brief summary
The study aims to compare two materials used in the reconstruction of orbital wall defects. Fractures of the orbital socket often occur following trauma. However, no data exists comparing the surgical outcomes between these two materials in correcting visual disturbances such as double vision, changes to eye position, visual acuity and accuracy of restoration. This study is necessary to determine if one material is superior to the other to guide future clinical decisions and material choices.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111454 0
Dr Darren Wang
Address 111454 0
Work/organisation:
Middlemore Hospital
Counties Manukau DHB
100 Hospital Road
Auckland 2025
Country 111454 0
New Zealand
Phone 111454 0
+64 211621692
Fax 111454 0
Email 111454 0
[email protected]
Contact person for public queries
Name 111455 0
Darren Wang
Address 111455 0
Work/organisation:
Middlemore Hospital
Counties Manukau DHB
100 Hospital Road
Auckland 2025
Country 111455 0
New Zealand
Phone 111455 0
+64 211621692
Fax 111455 0
Email 111455 0
[email protected]
Contact person for scientific queries
Name 111456 0
Darren Wang
Address 111456 0
Work/organisation:
Middlemore Hospital
Counties Manukau DHB
100 Hospital Road
Auckland 2025
Country 111456 0
New Zealand
Phone 111456 0
+64 211621692
Fax 111456 0
Email 111456 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11867Study protocol    382099-(Uploaded-31-05-2021-20-59-38)-Study-related document.docx



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.