Comparison of two implant materials for repair of orbital defects in patients with isolated orbital floor fractures.

Not Applicable

• Conditions: Orbital floor fractures; Surgery - Other surgery; Injuries and Accidents - Fractures

• Registration Number: ACTRN12621001069842
• Lead Sponsor: Counties Manukau DHB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-13
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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). <br>[Pre-operative (baseline), one month and three months post-operatively (primary endpoint)];Presence of enophthalmos following orbital reconstruction with titanium or titanium-reinforced porous polyethylene. To be assessed using Hertel's exophthalmometer. [Pre-operative (baseline), one month and three months post-operatively (primary endpoint)];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. [Pre-operative (baseline), one month and three months post-operatively (primary endpoint)]

Secondary Outcome Measures

Name	Time	Method
Subjective ease of material handling between titanium and titanium-reinforced porous polyethylene. To be tested using a Likert scale (1 easiest - 5 most difficult) [Immediately post-operatively];Magnitude of enophthalmos following orbital reconstruction with titanium or titanium-reinforced porous polyethylene. To be assessed using Hertel's exophthalmometer (assessed as primary outcome). [Pre-operative (baseline), one month and three months post-operatively (primary endpoint)]