None listed
Conditions
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.
Interventions
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 poly
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.
Sponsors
Counties Manukau DHB
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed