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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (patient specific titanium implant) | Active Comparator | (reconstruction with patient specific titanium implant) |
|
| Group B (preformed plate bended on stereolithographic model) | Active Comparator | (reconstruction with preformed titanium plate preoperatively bended on stereolithographic model) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| orbital bone reconstruction with patient specific titanium implant | Procedure | 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| changes in ocular motility pre and post-operative | assessment of motility of eye globe using extraocular muscle function test | preoperative and one week ,one month ,3rd and 6th month post operative |
| cost of the implant in US dollar |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hatem A Abo El Hassan El Shazly, MMed | Contact | +201002760859 | +201114455343 | hatem_adel_post@med.sohag.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Kamal A Hassanein, Professor | Sohag University | Study Chair |
| Tarek A Ftohy, Ass. prof | Sohag University | Study Director |
| Islam AA Amer, Ass. prof |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sohag faculty of medicine | Recruiting | Sohag | 82524 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31513039 | Background | Abbate V, Iaconetta G, Califano L, Pansini A, Bonavolonta P, Romano A, Salzano G, Somma T, D'Andrea L, Dell'Aversana Orabona G. Self-Made Rapid Prototyping Technique for Orbital Floor Reconstruction: Showcases for Technical Description. J Craniofac Surg. 2019 Oct;30(7):2106-2110. doi: 10.1097/SCS.0000000000006004. | |
| 27519662 | Background |
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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
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| orbital bone reconstruction with preformed titanium plate preoperatively bended on stereolithographic model | Procedure | 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. |
|
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 |
cost of the patient specific implant and the cost of the stereolithographic model and preformed titanium implant
| Through study completion, an average of 1 year |
| adverse events | implant displacement, bleeding, infection, pain | postoperative one week , 3rd and 6th moths postoperative |
| changes in patient satisfaction using scoring system from 1 to 5 | assessment of the patients satisfaction to the results post operative using scoring system from 1 to 5 in which :
| 1st, 3rd and 6th month post operative |
| duration of surgery | recording each procedure time | intraoperative |
| measurement of changes in visual acuity using A Snellen chart test | testing of visual acuity of the affected eye pre and post operative | preoperative and one week ,one month ,3rd and 6th month post operative |
| changes in aesthetic results using scoring system from 1 to 4 | assessment of changes in cosmetic results following surgery by one of the supervisors using a scoring system from 1 to 4 in which:
| 1st, 3rd and 6th month post operative |
| Sohag University |
| Study Director |
| Zimmerer RM, Ellis E 3rd, Aniceto GS, Schramm A, Wagner ME, Grant MP, Cornelius CP, Strong EB, Rana M, Chye LT, Calle AR, Wilde F, Perez D, Tavassol F, Bittermann G, Mahoney NR, Alamillos MR, Basic J, Dittmann J, Rasse M, Gellrich NC. A prospective multicenter study to compare the precision of posttraumatic internal orbital reconstruction with standard preformed and individualized orbital implants. J Craniomaxillofac Surg. 2016 Sep;44(9):1485-97. doi: 10.1016/j.jcms.2016.07.014. Epub 2016 Jul 21. |
| 29510812 | Background | Felding UNA. Blowout fractures - clinic, imaging and applied anatomy of the orbit. Dan Med J. 2018 Mar;65(3):B5459. |
| 21885249 | Background | Mustafa SF, Evans PL, Bocca A, Patton DW, Sugar AW, Baxter PW. Customized titanium reconstruction of post-traumatic orbital wall defects: a review of 22 cases. Int J Oral Maxillofac Surg. 2011 Dec;40(12):1357-62. doi: 10.1016/j.ijom.2011.04.020. Epub 2011 Aug 31. |
| 28828975 | Background | Raisian S, Fallahi HR, Khiabani KS, Heidarizadeh M, Azdoo S. Customized Titanium Mesh Based on the 3D Printed Model vs. Manual Intraoperative Bending of Titanium Mesh for Reconstructing of Orbital Bone Fracture: A Randomized Clinical Trial. Rev Recent Clin Trials. 2017;12(3):154-158. doi: 10.2174/1574887112666170821165206. |
| 1640125 | Background | Sugar AW, Kuriakose M, Walshaw ND. Titanium mesh in orbital wall reconstruction. Int J Oral Maxillofac Surg. 1992 Jun;21(3):140-4. doi: 10.1016/s0901-5027(05)80780-5. |
| 23306963 | Background | Bly RA, Chang SH, Cudejkova M, Liu JJ, Moe KS. Computer-guided orbital reconstruction to improve outcomes. JAMA Facial Plast Surg. 2013 Mar 1;15(2):113-20. doi: 10.1001/jamafacial.2013.316. |
| 32439600 | Background | Longeac M, Depeyre A, Pereira B, Barthelemy I, Pham Dang N. Virtual surgical planning and three-dimensional printing for the treatment of comminuted zygomaticomaxillary complex fracture. J Stomatol Oral Maxillofac Surg. 2021 Sep;122(4):386-390. doi: 10.1016/j.jormas.2020.05.009. Epub 2020 May 18. |
| 28642192 | Background | Scolozzi P. Applications of 3D orbital computer-assisted surgery (CAS). J Stomatol Oral Maxillofac Surg. 2017 Sep;118(4):217-223. doi: 10.1016/j.jormas.2017.05.007. Epub 2017 Jun 19. |
| ID | Term |
|---|---|
| D009917 | Orbital Fractures |
| D008441 | Maxillary Neoplasms |
| D015051 | Zygomatic Fractures |
| D009918 | Orbital Neoplasms |
| ID | Term |
|---|---|
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007573 | Jaw Neoplasms |
| D012888 | Skull Neoplasms |
| D001859 | Bone Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D007571 | Jaw Diseases |
| D008439 | Maxillary Diseases |
| D009057 | Stomatognathic Diseases |
| D005134 | Eye Neoplasms |
| D005128 | Eye Diseases |
| D009916 | Orbital Diseases |
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