Interlocking Polyetheretherketone Implants for Orbital Floor Reconstruction

Not Applicable

• Conditions: Large Orbital Floor Fracture

• Registration Number: NCT06661785
• Lead Sponsor: Tanta University

Brief Summary

Patients with large orbital floor fracture were reconstructed with interlocking polyetheretherketone patient-specific implant and will be evaluated clinically and radiographically

Detailed Description

Twenty two patients with large orbital floor fracture will be included in this study. Patients will be received, examined and managed at the Oral \& Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University. Full clinical examination and radiographic examination using multi axial C.T Scan for proper diagnosis and treatment planning. DICOM files will be imported into surgical planning software and used for fabrication of interlocking polyetheretherketone patient specific implant which will be ready for sterilization and insertion. After written informed consent from the patient, the surgery will be done under G.A, either infraorbital or transconjunctival incision will be done according to the case. Follow up: All patients will be examined clinically for hypoglobus, enophthalmos, ocular motility and diplopia during 2nd week, 1st month and 6 months \& radiographically for orbital volume immediately and 6 months postoperatively

Study Timeline

• Study Start: 2024-04-25
• Primary Completion: 2024-07-25
• Status Verified: 2024-10
• Study First Submitted: 2024-10-22
• Study First Submitted QC: 2024-10-25
• Study First Posted: 2024-10-28
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11
• Study Completion: 2025-05-25

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Patients with large orbital blow out fracture either isolated or combined with other fracture
• Patients willing for surgical operation and follow up
• Patients with no contraindications for surgical intervention

Exclusion Criteria

• Patients who are not fit for G.A
• Uncooperative patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Hypoglobus	2 weeks	It is the downward displacement of the eyeball of affected eye. It is measured by drawing imaginary line horizontally across the patient's inter-pupillary axis and determine if the pupil of the affected eye is lower or not
Enophthalmos	2 weeks	It is defined as the posterior displacement of the eyeball within the orbit. It was measured by the aid of exophthalmometer. Assessment is consisting of four grades as follow: grade 0:no enophthalmos grade 1:mild enophthalmos(less than 1 mm) grade 2:moderate enophthalmos(from 1 to 2 mm) grade 3:severe enophthalmos(over 2 mm)
Orbital volume	2 weeks	C.T. images of the patient are imported in DICOM format into the automatic orbital analysis software and the orbital volume of both orbital cavities are measured
Ocular motility	2 weeks	It is done by asking the patient to follow a moving target into the diagnostic positions of gaze, observing the extent of movement of each eye. The amount of limitation of movement is classified as: grade 1:slight limitation grade 2:moderate limitation grade 3:marked limitation grade 4:no movement
Diplopia	2 weeks	It is defined as perception of two images of the same object in visual space. It is assessed if it is present in primary position of gaze or in secondary position of gaze

Secondary Outcome Measures

Name	Time	Method
Hypoglobus	6 months	It is the downward displacement of the eyeball of affected eye. It is measured by drawing imaginary line horizontally across the patient's inter-pupillary axis and determine if the pupil of the affected eye is lower or not
Orbital volume	6 months	C.T. images of the patient are imported in DICOM format into the automatic orbital analysis software and the orbital volume of both orbital cavities are measured
Diplopia	6 months	It is defined as perception of two images of the same object in visual space. It is assessed if it is present in primary position of gaze or in secondary position of gaze
Enophthalmos	6 months	It is defined as the posterior displacement of the eyeball within the orbit. It was measured by the aid of exophthalmometer. Assessment is consisting of four grades as follow: grade 0:no enophthalmos grade 1:mild enophthalmos(less than 1 mm) grade 2:moderate enophthalmos(from 1 to 2 mm) grade 3:severe enophthalmos(over 2 mm)
Ocular motility	6 months	It is done by asking the patient to follow a moving target into the diagnostic positions of gaze, observing the extent of movement of each eye. The amount of limitation of movement is classified as: grade 1:slight limitation grade 2:moderate limitation grade 3:marked limitation grade 4:no movement

Trial Locations

Locations (1)

Faculty of Dentistry, Tanta University; 🇪🇬 Tanta, Egypt