Application of CAD-CAM Technology in Orbital Bone Reconstruction

Study Overview
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Brief Summary
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Reconstruction of orbital defects resulting after trauma; tumor resection; maxillary cyst; craniofacial anomalies and sequestrated bone…. etc., has been a challenging issue over the years and this owing to the complicated anatomy of orbit. Inaccurate orbital reconstruction may lead to devastating cosmetic and functional complications. Titanium mesh for orbital reconstruction has now become probably the most popular material for orbital wall reconstruction worldwide. Innovation of CAD-CAM technology and its application in maxillofacial surgery will markedly improve the surgical outcome. This study will assess the accuracy of orbital reconstruction using CAD-CAM technology and to compare two different modalities for orbital reconstruction based on this technology.

Detailed Description
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This study will be a prospective cohort study. It will include patients treated with the custom-made implants for orbital blow out fractures, ZMC fractures or tumors. The sample will consist of 34 patients who will need orbital reconstruction and will be operated in Maxillofacial, Head and Neck Unit, General Surgery Department, Faculty Of Medicine, Sohag University, Egypt. The patients will be randomly divided into two groups, group (A) reconstructed with patient specific implant and group (B) reconstructed with preformed plate preoperatively bended on stereolithographic model. The reconstructive outcomes are assessed by clinical and ophthalmological examinations and accuracy analysis by comparing the preoperative and postoperative multi slice computed tomography data. All patients will be assessed clinically, ophthalmologically, and radiographically using computed tomography (CT) then virtual surgical planning and custom-made patient implant will be manufactured. Post-operative clinical evaluation will be done, and radiographic evaluation of all patients will be done by CT scan within one week and 6 months after the procedure. comparing data of the two groups will be done using appropriate methods.

Official Title
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Comparison of Two Different Modalities for Orbital Reconstruction Based on CAD-CAM Technology: A Clinical Randomized Trial

Conditions
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Orbital Bone Fracture, Maxillary Cyst, Maxillary Neoplasms, Zygomatic Fractures, Orbital Neoplasms, Facial Deformity

Intervention / Treatment
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* Procedure: orbital bone reconstruction with patient specific titanium implant
* Procedure: orbital bone reconstruction with preformed titanium plate preoperatively bended on stereolithographic model


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: fracture of the orbital floor and/or medial wall and/or lateral wall. complex fracture of the zygomatic bone (those affecting orbital volume). Old orbital fractures on either side causing enophthalmos, diplopia, cosmetic asymmetry. Periorbital neoplasm affecting orbital volume and need surgical resection Exclusion Criteria: injury to the globe that restricts surgical reconstruction. neurological diseases with influence on eye motility or sight. Patients with special needs. Medically compromised patients who are not fit for surgery. Patients refused participation in this study.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: the participants are assigned to two groups randomly A and B and receive two different intervention modality throughout the study and the results will be compared between the two groups
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A (patient specific titanium implant)<br>(reconstruction with patient specific titanium implant) | Procedure: orbital bone reconstruction with patient specific titanium implant<br>* orbital defects reconstruction will be virtually planned by software and a patient specific titanium implant will be manufactured using milling technique depending on CAD-CAM technology<br>|
| Active Comparator: Group B (preformed plate bended on stereolithographic model)<br>(reconstruction with preformed titanium plate preoperatively bended on stereolithographic model) | Procedure: orbital bone reconstruction with preformed titanium plate preoperatively bended on stereolithographic model<br>* orbital defects reconstruction will be virtually planned by software and a reconstructed stereolithographic model will be 3D printed and used for preoperatively bending of preformed titanium implant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement of Changes in orbital bony volume | pre and post operative reconstructed orbit volume will be measured using multi slice computed tomography (MSCT) image loaded on software and compared with preoperative and with healthy non affected orbit | preoperative and one week and 6 months post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement of Changes in globe position in the bony orbit | pre and post operative measurement of globe position within the bony orbit using MSCT image loaded on software and comparing measures with preoperative and with healthy non affected orbit | preoperative and one week and 6 months post operative | 
| measurement of Changes in zygomaticomaxillary complex symmetry | in patients with associated ZMC affection, symmetry with the healthy side and prominence of the zygomatic eminence will be measured using MSCT image loaded on software and compared with preoperative and with healthy non affected ZMC | preoperative and one week and 6 months post operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orbital bone reconstruction, zygomaticomaxillary complex fracture (ZMC), patient specific implant, preformed plates, CAD-CAM