Interlocking Polyetheretherketone Implants for Orbital Floor Reconstruction

Tanta University

Status: Invitation-only

Conditions: Large Orbital Floor Fracture

Treatments: Procedure: large orbital floor fracture

Study type: Interventional

Funder types: Other

Identifiers

NCT06661785

#R-OS-12-22-3

Details and patient eligibility

About

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

Full 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

Enrollment: 22 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Interlocking polyetheretherketone patient specific implant for orbital floor reconstruction

Experimental group

Description:

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

Treatment:

Procedure: large orbital floor fracture