Trials / Unknown
UnknownNCT03484676
Adequacy of One Point Fixation of Displaced Zygomatic Complex Fracture
Adequacy of One-Point Fixation of Displaced Zygomatic Complex Fractures Using a Customized Plate pre_post Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- Sponsor
- Cairo University · Academic / Other
- Sex
- All
- Age
- 15 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Patients with unilateral non-comminuted zygomatic complex fracture undergo fixation of the complex by a customized plate at one point after 3D virtual simulation and reduction of the complex using Mimics software.
Detailed description
History data will be gathered including personal data, medical and surgical history, and family history. Clinical examination and photographic records will be carried out to evaluate the magnitude and direction of the displaced zygoma, degree of facial asymmetry, neurosensory affection and functional disturbances. Computed tomography (CT) scan: Patients will receive a preoperative computed tomography (CT) scan of the facial bones \[ Axial cuts, DICOM file, Gantry tilt zero and minimal thickness of 1 mm\]. The radiographic data will be imported into a surgical simulation software to virtually reduce the fractured zygoma and custom design the plate for fixation. General operative procedures: * All cases will undergo surgery under general anesthesia with nasotracheal intubation. * Intraoral maxillary vestibular approach will be used to gain access to the fractured zygomatic complex. Reduction of the fractured segment would be achieved using the appropriate techniques and instrumentation. One point ORIF would be accomplished using the customized plate.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Titinium | custom made plate at one point after 3D virtual simulation and reduction of the complex using Mimics software. |
Timeline
- Start date
- 2018-03-01
- Primary completion
- 2018-07-01
- Completion
- 2018-10-01
- First posted
- 2018-04-02
- Last updated
- 2018-04-02
Source: ClinicalTrials.gov record NCT03484676. Inclusion in this directory is not an endorsement.