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Completed

NCT Number: NCT06661785

Interlocking Polyetheretherketone Implants for Orbital Floor Reconstruction

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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Key information

Conditions

Large Orbital Floor Fracture

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Tanta University

Tanta, 31527, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

large orbital floor fracture

Procedure

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

Primary outcomes

  1. Hypoglobus

    Time frame: 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

  2. Enophthalmos

    Time frame: 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)

  3. Orbital volume

    Time frame: 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

  4. Ocular motility

    Time frame: 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

  5. Diplopia

    Time frame: 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 outcomes

  1. Hypoglobus

    Time frame: 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

  2. Enophthalmos

    Time frame: 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)

  3. Orbital volume

    Time frame: 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

  4. Ocular motility

    Time frame: 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

  5. Diplopia

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Interlocking Polyetheretherketone Patient-Specific Implants for Orbital Floor Reconstruction

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Oct 28, 2024
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.