Facial Deformity, Maxillary Cyst, Maxillary Neoplasms, Orbital Bone Fracture, Orbital Neoplasms, Zygomatic Fractures
Conditions
Keywords
Orbital bone reconstruction, zygomaticomaxillary complex fracture (ZMC), patient specific implant, preformed plates, CAD-CAM
Brief summary
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
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.
Interventions
PROCEDUREorbital bone reconstruction with patient specific titanium implant
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
PROCEDUREorbital bone reconstruction with preformed titanium plate preoperatively bended on stereolithographic model
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.
Sponsors
Hatem Adel Aboelhassan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention 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
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| measurement of Changes in orbital bony volume | preoperative and one week and 6 months post-operative | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| measurement of Changes in globe position in the bony orbit | preoperative and one week and 6 months post operative | 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 |
| measurement of Changes in zygomaticomaxillary complex symmetry | preoperative and one week and 6 months post operative | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| cost of the implant in US dollar | Through study completion, an average of 1 year | cost of the patient specific implant and the cost of the stereolithographic model and preformed titanium implant |
| adverse events | postoperative one week , 3rd and 6th moths postoperative | implant displacement, bleeding, infection, pain |
| duration of surgery | intraoperative | recording each procedure time |
| changes in aesthetic results using scoring system from 1 to 4 | 1st, 3rd and 6th month post operative | assessment of changes in cosmetic results following surgery by one of the supervisors using a scoring system from 1 to 4 in which: * 1 = Excellent * 2 = good * 3 = Fair * 4 = poor |
| changes in patient satisfaction using scoring system from 1 to 5 | 1st, 3rd and 6th month post operative | assessment of the patients satisfaction to the results post operative using scoring system from 1 to 5 in which : * 1 = Excellent * 2 = good * 3 = Fair * 4 = not bad * 5 = poor |
| measurement of changes in visual acuity using A Snellen chart test | preoperative and one week ,one month ,3rd and 6th month post operative | testing of visual acuity of the affected eye pre and post operative |
| changes in ocular motility pre and post-operative | preoperative and one week ,one month ,3rd and 6th month post operative | assessment of motility of eye globe using extraocular muscle function test |
Countries
Egypt
Contacts
Primary ContactHatem A Abo El Hassan El Shazly, MMed
Outcome results
None listed