Skip to main content
Clinical Trials/ACTRN12621001069842
ACTRN12621001069842
Not Yet Recruiting
N/A

Comparison of Titanium Plates with Titanium-Reinforced Polyethylene for the Reconstruction of Orbital Floor Defects: A Randomised Controlled Trial

Counties Manukau DHB0 sites40 target enrollmentAugust 13, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Orbital floor fractures
Sponsor
Counties Manukau DHB
Enrollment
40
Status
Not Yet Recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 13, 2021
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Counties Manukau DHB

Eligibility Criteria

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.

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.

Outcomes

Primary Outcomes

Not specified

Similar Trials