Application of CAD-CAM Technology in Orbital Bone Reconstruction

Zygomatic Fractures Clinical Trial

— CAD-CAM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05438784
• Other study ID #: Soh-Med-22-06-18
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: June 2022
• Source: Sohag University
• Contact: Hatem A Abo El Hassan El Shazly, MMed
• Phone: +201002760859
• Email: hatem_adel_post[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: June 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Facial Deformity
• Fractures, Bone
• Maxillary Cyst
• Maxillary Neoplasms
• Neoplasms
• Orbital Fractures
• Zygomatic Fractures

Intervention

Procedure:
• orbital 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
• orbital 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.

Locations

Country	Name	City	State
Egypt	Sohag faculty of medicine	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Hatem Adel Aboelhassan

Country where clinical trial is conducted

Egypt, 

References & Publications (9)

Abbate V, Iaconetta G, Califano L, Pansini A, Bonavolontà 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. — View Citation

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. — View Citation

Felding UNA. Blowout fractures - clinic, imaging and applied anatomy of the orbit. Dan Med J. 2018 Mar;65(3). pii: B5459. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Sugar AW, Kuriakose M, Walshaw ND. Titanium mesh in orbital wall reconstruction. Int J Oral Maxillofac Surg. 1992 Jun;21(3):140-4. — View Citation

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, Bašic 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	cost of the implant in US dollar	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
Other	adverse events	implant displacement, bleeding, infection, pain	postoperative one week , 3rd and 6th moths postoperative
Other	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 : 1 = Excellent; 2 = good; 3 = Fair; 4 = not bad; 5 = poor	1st, 3rd and 6th month post operative
Other	duration of surgery	recording each procedure time	intraoperative
Other	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
Other	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: 1 = Excellent; 2 = good; 3 = Fair; 4 = poor	1st, 3rd and 6th month post operative
Primary	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	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
Secondary	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