Interlocking Polyetheretherketone Implants for Orbital Floor Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-25

Study Completion Date

2025-11-02

Brief Summary

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

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Detailed Description

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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

Conditions

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Large Orbital Floor Fracture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interlocking polyetheretherketone patient specific implant for orbital floor reconstruction

This study is conducted on twenty two patients with unilateral large orbital floor fracture reconstructed with interlocking polyetheretherketone patient specific implant

Group Type EXPERIMENTAL

large orbital floor fracture

Intervention Type PROCEDURE

Twenty two patients with large orbital floor fracture will be reconstructed with interlocking polyetheretherketone patient-specific implant

Interventions

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large orbital floor fracture

Twenty two patients with large orbital floor fracture will be reconstructed with interlocking polyetheretherketone patient-specific implant

Intervention Type PROCEDURE

Eligibility Criteria

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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