Patient-specific PEEK Implants for Post-maxillectomy Orbital Floor Reconstruction

Alexandria University6 enrolled

Overview

The study aims to evaluate the utilization of Patient-specific PEEK implantsd in reconstruction of orbital floor after maxilla ablation surgery

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Orbital Floor Reconstruction PEEK IMPLANTS MAXILLECTOMY

Interventions

Patient-specific PEEK implantsDEVICE

patients will be treated by Brown class III maxillectomy and immediate orbital floor reconstruction by Patient-specific PEEK implants

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1\. Unilateral invasive benign or malignant tumors of the maxilla that requires orbital floor resection. 3\. Brown class III maxillectomy defects patients 2. Patients with immediate orbital floor reconstruction will be enrolled in this study. Exclusion Criteria: 1. Medically compromised patients contradicting operation. 2. Delayed orbital floor reconstruction cases will be excluded. 3. Bilateral cases will be excluded.

Locations (1)

Faculty of dentistry, Alexandria university

Alexandria, Egypt

Outcomes

Primary Outcomes

Enophthalmos analysis

On the axial cuts, at the level of a horizontal dissecting line (Baseline) was drawn joining the anterior tips of the lateral orbital margin bilaterally. The perpendicular distance from the top of the corneal bulge to this line was measured for both the affected and the contralateral globes. The difference in the measurement value between the normal and the affected orbit was used to conclude the presence or absence of enophthalmos, or proptosis of the orbit, using the equation (Globe Δ = Contralateral value-Ipsilateral Value). A reported difference between both globes of more than 2 mm is designated as enophthalmos

Time frame: Immediately after the surgery

Orbital Volume Evaluation

An appraisal of the orbital volume will be performed as an objective evaluation modality for the assessment of the accuracy of orbital floor reconstruction after Brown class III maxillectomies in both groups. A virtual orbital model of the reconstructed eye will be created using manual segmentation module in the 3D segmentation and image analysis software\* for the following: * Ipsilateral preoperative virtually reconstructed orbit. * Ipsilateral immediate postoperative CT-scan of the reconstructed orbit. * Contralateral preoperative and immediate postoperative orbit. The volume of the created orbital model will be automatically calculated and the mean value for each model will be calculated. In each group, efficiency of orbital floor reconstruction will be evaluated by comparing the postoperative value with the preoperative one and with the normal contralateral side.

Time frame: Immediately after the surgery

Secondary Outcomes

Ocular postoperative complications

Postoperative ocular complications such as the presence of ectropion, entropion, scleral show, corneal abrasion, , which will be assessed by asking the patient to describe his vision in the six cardinal positions of gaze monocularly

Time frame: 1 week postopreatively

Ocular motility and Diplopia

Ocular motility and diplopia were assessed using the "follow my finger" test. The test will be conducted by asking the patient to describe his vision in the six cardinal positions of gaze monocularly.

Data from ClinicalTrials.gov

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