Application of CAD-CAM Technology in Orbital Bone Reconstruction

NCT05438784 | Unknown

• 1 other identifier: Soh-Med-22-06-18
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Orbital Bone Fracture; Maxillary Cyst; Maxillary Neoplasms; Zygomatic Fractures; Orbital Neoplasms; Facial Deformity

Keywords

Orbital bone reconstruction; zygomaticomaxillary complex fracture (ZMC); patient specific implant; preformed plates; CAD-CAM

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• measurement of Changes in globe position in the bony orbit

  preoperative and one week and 6 months post operative

• measurement of Changes in zygomaticomaxillary complex symmetry

  preoperative and one week and 6 months post operative

Other Outcomes (7)

• changes in ocular motility pre and post-operative

  preoperative and one week ,one month ,3rd and 6th month post operative

• cost of the implant in US dollar

  Through study completion, an average of 1 year

• adverse events

  postoperative one week , 3rd and 6th moths postoperative

Study Arms (2)

Group A (patient specific titanium implant)

ACTIVE COMPARATOR

(reconstruction with patient specific titanium implant)

Procedure: orbital bone 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)

Procedure: orbital bone reconstruction with preformed titanium plate preoperatively bended on stereolithographic model

Interventions

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

Group A (patient specific titanium implant)

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.

Group B (preformed plate bended on stereolithographic model)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hatem Adel Aboelhassan: lead

Study Sites (1)

Sohag faculty of medicine

Sohag, 82524, Egypt

RECRUITING

Related Publications (9)

• 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.

  PMID: 31513039 BACKGROUND

• 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.

  PMID: 27519662 BACKGROUND

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

  PMID: 29510812 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.

  PMID: 21885249 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.

  PMID: 28828975 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.

  PMID: 1640125 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.

  PMID: 23306963 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.

  PMID: 32439600 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.

  PMID: 28642192 BACKGROUND

MeSH Terms

Conditions

Orbital Fractures; Maxillary Neoplasms; Zygomatic Fractures; Orbital Neoplasms

Condition Hierarchy (Ancestors)

Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries; Jaw Neoplasms; Skull Neoplasms; Bone Neoplasms; Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Jaw Diseases; Maxillary Diseases; Stomatognathic Diseases; Eye Neoplasms; Eye Diseases; Orbital Diseases

Study Officials

• Kamal A Hassanein, Professor

  Sohag University

  STUDY CHAIR

• Tarek A Ftohy, Ass. prof

  Sohag University

  STUDY DIRECTOR

• Islam AA Amer, Ass. prof

  Sohag University

  STUDY DIRECTOR

Central Study Contacts

Hatem A Abo El Hassan El Shazly, MMed

CONTACT

+201002760859; hatem_adel_post@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: specialist of maxillofacial, head and neck surgery

Model Details: 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

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 30, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

EG (1)