The Accuracy of Reconstruction of Orbital Walls Fracture Using Prebent Mesh Versus Patient Specific Implant

Orbital Fractures Clinical Trial

Official title:

The Accuracy of Reconstruction of Orbital Walls Fracture Using Prebent Mesh Versus Patient Specific Implant : A Prospective Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06294535
• Other study ID #: 2024
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 11, 2023
• Est. completion date: June 6, 2024

Study information

• Verified date: March 2024
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

under GA, incision to access to orbital walls. Then insertion of prebent titanium mesh or customized titanium implant and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap.

Description:

under GA, incision to access to orbital walls. complete reflection of orbital floor to be constructed then insertion of customized orbital implant of patient or insertion of titanium mrsh after adaption on the model and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: June 6, 2024
• Est. primary completion date: May 18, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• patient had fractured orbital walls suffering from enophthalmous, hypoglobus, diplopia

Exclusion Criteria:

• systemic disease interfere with bone healing enophthamous less than 2 mm

Related Conditions & MeSH terms

• Fractures, Bone
• Orbital Fractures

Intervention

Device:
• reconstruction of orbital walls
under GA, incision to access to orbital walls. Then insertion of prebent titanium mesh or customized titanium implant and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Tanta University	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	restoring the accurate position of eye	using exophthalmometer to measure enophthalmous	one month- six months
Primary	motility of eye	using 9 gaze test to evaluate motility of eye	one month
Primary	volume of orbit	using CT scan to measure orbital volume pre and postoperative	one to six months