Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369129
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-06
Brief Title:
Accuracy Orbital Volume Using Patient Specific Titanium Implant Vs Zirconia for Orbital Floor Reconstruction
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 16 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
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 16 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None