The Role of Prebent Titanium Mesh With 3D-Printed Model in Reconstruction of Zygomatico-Orbital Fractures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tanta University
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Area of bone defect (Orbital symmetry)
Study Overview
Brief Summary
Purpose: The aim of this study was to evaluate the role of using a prebent titanium mesh on a 3D-printed model as an intraoperative guide to reconstruct orbito-zygomatic-maxillary complex (OZMC) fractures.
Subjects and method: This is a prospective, interventional, longitudinal, single armed case series study that was carried out on twelve patients with unilateral displaced orbito-zygomatico-maxillary complex (OZMC) fracture indicated for orbital floor reconstruction as evidenced by clinical and radiographic examination. Open reduction and internal fixation were utilized to treat those fractures, patients were collected from the department of Oral and Maxillofacial surgery, Faculty of Dentistry, Tanta University. Post-operative evaluation: all patients underwent regular follow up for six months. The following parameters were evaluated: visual acuity, external appearance of the eye including hypoglobus and enophthalmos, diplopia, ocular motility, the aesthetic results, orbital volume, area of bone defect, layout angle, gab length and the zygomatic reconstruction.
Detailed Description
This study was conducted on twelve patients with unilateral displaced OZMC fracture indicated for orbital floor reconstruction as evidenced by clinical and radiographic examination. The patients' ages ranged from 18-55 years old. All patients were evaluated preoperatively for collecting demographic data, taking general medical, surgical, and dental history and for determining the main patient's chief complaints and postoperative expectations. Approval for this project was obtained from Research Ethics Committee (REC) of faculty of Dentistry, Tanta University. The purpose of the present study was explained to the patients and informed consents were obtained according to the guidelines of human research adopted by the REC at Faculty of Dentistry, Tanta University. After obtaining the preoperative CT scan, 3D simulation was performed using (3Diagnosys, version 4.2, 3diemme. Como, Italy) as the following steps:
- Importing CT DICOM images.
- Mirror image of the normal side.
- Segmentation to remove any unwanted areas.
- Thresholding to choose the density of bone.
- Conversion to STL format.
- Exporting as an STL file to the 3D printer. The 3D printer (Upbox, Tiertime, Korea) was used to print the patient specific model. The Printing material was ABS/PLA. The technology used for the printing process was FDM (Fused Deposition Modeling), where a filament is heated above 200 degrees and extruded through a nozzle of 0.4 mm diameter to print layer by layer with a resolution of 100 microns. Routine preoperative investigations (complete blood picture, prothrombin test, liver &renal function test and viral profile) were done for all patients, together with relevant medical consultation when required. The patients were operated under general anesthesia via nasal endotracheal intubation. The surgical site was disinfected using Povidone-iodine then isolated and draped with sterile dressing. Reconstruction was done carefully. All outcome measures were measured later on, and adequate statistical analysis was performed.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with unilateral displaced zygomatico-orbital fracture (with fractured orbital floor).
- •Patients with no previous history of orbital reconstruction.
- •Diplopia within 30° of primary gaze.
- •Radiological evidence of extraocular muscle entrapment and/or positive forced duction test.
- •Enophthalmos of more than 2mm.
Exclusion Criteria
- •Bilateral zygomatico-orbital fractures.
- •Rupture of the globe.
- •Retinal detachment.
- •Traumatic optic nerve lesions.
Arms & Interventions
Only single arm of the study
This is the only arm of the study containing 12 patients who will be operated for reconstruction for unilateral OZMC fracture. A lot of outcome measures will be measured to evaluate the effectiveness of the intervention.
Intervention: Zygomatico-Orbital reconstruction (Procedure)
Outcomes
Primary Outcomes
Area of bone defect (Orbital symmetry)
Time Frame: Preoperatively. Postoperatively within two weeks after the operation.
By obtaining CT scan of the face then the DICOM data was imported by BONELOGIC CMF ORBITAL software provided by Disior company which performed automated 3D analysis for the orbits preoperatively and postoperatively.
Acuraccy of Orbito-Zygomatico-maxillary complex fracture reconstruction
Time Frame: Only postoperatively within two weeks after the operation.
On a postoperative CT scan of the face adequate zygomatic reduction was judged by evaluating any involved parts from the following reference points, including zygomaticofrontal suture, zygomatico-sphenoidal suture, zygomaticomaxillary buttress, inferior orbital rim, and zygomatic arch, which was judged by two experienced surgeons as good, satisfactory or poor.
Orbital volume
Time Frame: Preoperatively. Postoperatively within two weeks after the operation.
By obtaining CT scan of the face then the DICOM data was imported by BONELOGIC CMF ORBITAL software provided by Disior company which performed automated 3D analysis for the orbits preoperatively and postoperatively.
Secondary Outcomes
- Diplopia(Preoperative. Postoperatively 2 weeks, 1 month, 2 months, 3 months and 6 months.)
- The layout angle(Only postoperatively within two weeks after the operation.)
- Visual acuity(Preoperative. Postoperatively 2 weeks, 1 month, 2 months, 3 months and 6 months.)
- Vertical dystopia(Preoperative. Postoperatively 2 weeks, 1 month, 2 months, 3 months and 6 months.)
- Enophthalmos(Preoperative. Postoperatively 2 weeks, 1 month, 2 months, 3 months and 6 months.)
- Ocular motility(Preoperative. Postoperatively 2 weeks, 1 month, 2 months, 3 months and 6 months.)
- The gap length(Only postoperatively within two weeks after the operation.)
Investigators
AYMAN M. ARAKEEP, MSc, PhD researcher
Assistant Lecturer of Oral & Maxillofacial Surgery
Tanta University