Accuracy& Orbital Volume Using Patient Specific Titanium Implant Vs Zirconia for Orbital Floor Reconstruction

Assessment of Accuracy and Orbital Volume Using Patient Specific Titanium Implant Vs Patient Specific Zirconia Implant for Orbital Floor Reconstruction in Blowout Fractures A Randomized Clinical Trial: Comparative Study

Comparative study used to assess if the patient specific zirconia implant will provide better accuracy, intraoperative adaptability, precise orbital volume and soft tissue reaction with more cost effectiveness than the patient specific titanium implants in orbital floor reconstruction after blow out fractures .

Study Overview

• Status: Recruiting
• Conditions: Orbital Fractures; Orbital Floor Fracture; Orbital Trauma; Blow-Out Fractures
• Intervention / Treatment: Procedure: Orbital floor reconstruction with Patient Specific Zirconia Implant; Procedure: Orbital floor reconstruction with Patient Specific Titanium Implant

Detailed Description

Patients of both groups will be subjected to:

1. Case history including personal data, medical, surgical history and family history.
2. A full examination of the cranial and maxillofacial skeleton and soft tissue .
3. Evaluation of Visual Functions
4. Ophthalmologic consultation and clearance
5. Radiographic examination: CT scan
6. All DICOM data will be imported to the surgical planning software.

Virtual planning:

1. A midsagittal plane will be constructed then the normal orbit will be mirrored to the affected side.
2. The mirrored orbital floor will be meshed with 1.6 mm holes then its peripheries will be extended downwards by 3 mm and meshed also in order to accommodate the fixation.

3. The designed part will be subtracted then exported in Stereolithography (STL) format to be fabricated .

   The surgery will be done under General anesthesia and undertaken within 14 days to prevent fibrosis. Can be delayed 24-72 hours to allow the edema to subside before undertaking surgery.

   Intervention Group: -

   • The STL file will be milled from zirconium and then will be ready for sterilization and intraoperative fixation

   - A transconjunctival incision will be done to allow for good exposure that optimizes visualization of the orbital floor during the repair and insertion and fixation of the patient specific zirconia implant.

   Control Group: -

   • The STL file be milled from grade 4 titanium and then will be ready for sterilization and intraoperative fixation with the same surgical steps.

   Follow up:

   All patients will be examined clinically and radiographically, during postoperative 1st and 2nd week .

   Only one postoperative CT scan will be done after 2 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: OLA A. ELMORSY, PHD; Phone Number: 00201141234877; Email: dr.ola.elmorsy@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11511
    • Recruiting
    • Cairo University
    • Contact: OLA A. ELMORSY, PHD; Phone Number: 00201141234877; Email: dr.ola.elmorsy@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients with blow out fracture isolated and / or combined with other fracture.
• Age group: from 18 to 60 years old
• No sex predilection
• Patients with no contraindications to surgical intervention.
• Patients willing for the surgical procedure and follow-up, with an informed consent.

Exclusion Criteria :

• Medically compromised patients.
• Patients with history of previous orbital reconstruction surgery.
• Uncooperative patients.
• Patients with systemic contraindication to general anesthesia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Orbital floor reconstruction with Patient Specific Zirconia Implant; Orbital floor reconstruction with Patient Specific Zirconia Implant will be done	Procedure: Orbital floor reconstruction with Patient Specific Zirconia Implant; Orbital floor reconstruction with Patient Specific Zirconia Implant will be done
Active Comparator: Orbital floor reconstruction with Patient Specific Titanium Implant; Orbital floor reconstruction with Patient Specific Titanium Implant will be done.	Procedure: Orbital floor reconstruction with Patient Specific Titanium Implant; Orbital floor reconstruction with Patient Specific Titanium Implant will be done

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Orbital Volume	will be measured with CT scan in mm3	immediately post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of the patient specific implant in the orbital floor reconstruction	will be measured with CT scan with superimposition of the preoperative CT scan and the mirrored image and the post operative CT scan . The difference will be measured by mm	immediately post operative
Cost effectiveness	will compare between the prices of the patient specific implants the titanium and the zirconia and financial record will be kept with that in United states dollar . By the end of the study and comparison will be done to check which one was more cost effective	through study completion, an average of 1 year
Patient satisfaction	will be assessed by a Questionnaire using Visual analogue scale , highest score will be more satisficed .The score is minimum 1 and maximum 10.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: OLA A. ELMORSY, PHD, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: April 6, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Maxillofacial Injuries; Facial Injuries; Skull Fractures; Fractures, Bone; Orbital Fractures
• Other Study ID Numbers: CEBD-CU-2024-06-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No