Application of CAD-CAM Technology in Orbital Bone Reconstruction (CAD-CAM)

June 25, 2022 updated by: Hatem Adel Aboelhassan

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Sohag, Egypt, 82524
        • Recruiting
        • Sohag Faculty of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A (patient specific titanium implant)
(reconstruction with patient specific titanium implant)
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
Active Comparator: Group B (preformed plate bended on stereolithographic model)
(reconstruction with preformed titanium plate preoperatively bended on stereolithographic model)
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurement of Changes in orbital bony volume
Time Frame: 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
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
Time Frame: 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
preoperative and one week and 6 months post operative
measurement of Changes in zygomaticomaxillary complex symmetry
Time Frame: 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
preoperative and one week and 6 months post operative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in ocular motility pre and post-operative
Time Frame: preoperative and one week ,one month ,3rd and 6th month 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
Time Frame: 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
Through study completion, an average of 1 year
adverse events
Time Frame: postoperative one week , 3rd and 6th moths postoperative
implant displacement, bleeding, infection, pain
postoperative one week , 3rd and 6th moths postoperative
changes in patient satisfaction using scoring system from 1 to 5
Time Frame: 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
1st, 3rd and 6th month post operative
duration of surgery
Time Frame: intraoperative
recording each procedure time
intraoperative
measurement of changes in visual acuity using A Snellen chart test
Time Frame: preoperative and one week ,one month ,3rd and 6th month post operative
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
Time Frame: 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
1st, 3rd and 6th month post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hatem Adel Aboelhassan

Investigators

  • Study Chair: Kamal A Hassanein, Professor, Sohag University
  • Study Director: Tarek A Ftohy, Ass. prof, Sohag University
  • Study Director: Islam AA Amer, Ass. prof, Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

June 21, 2022

First Submitted That Met QC Criteria

June 25, 2022

First Posted (Actual)

June 30, 2022

Study Record Updates

Last Update Posted (Actual)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 25, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-22-06-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Orbital Neoplasms

Clinical Trials on orbital bone reconstruction with patient specific titanium implant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe