MAXILLECTOMY, Orbital Floor Reconstruction, PEEK IMPLANTS
Conditions
Brief summary
The study aims to evaluate the utilization of Patient-specific PEEK implantsd in reconstruction of orbital floor after maxilla ablation surgery
Interventions
DEVICEPatient-specific PEEK implants
patients will be treated by Brown class III maxillectomy and immediate orbital floor reconstruction by Patient-specific PEEK implants
Sponsors
Alexandria University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enophthalmos analysis | Immediately after the surgery | 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 |
| Orbital Volume Evaluation | Immediately after the surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular postoperative complications | 1 week postopreatively | 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 |
| Ocular motility and Diplopia | 1 week postopreatively | 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. |
Countries
Egypt
Outcome results
None listed