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this study aims To evaluate The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fracture reduction and fixation Using customized Patient-Specific implant and patient-specific predictive holes surgical guide Versus Conventional Technique of reduction and fixation.
The ZMC has multiple points of articulation with the craniofacial skeleton making accurate assessment of reduction at all articulations intraoperative in multiple planes very challenging and the interference of soft tissue edema and a narrowed visual field increases the possibility of intraoperative overcorrection or underestimation of pre-injured position of all fracture lines at the same time resulting in a suboptimal reduction. As a trial to maximize the benefits of digital planning carrying the plan into a real operating room using a patient-specific surgical guide to predrill screw holes and guide patient-specific implants during fixation according to the planning depend on CT scan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Experimental | all cases that will be allocated in this group will undergo treatment using a full digital protocol depending on planning software and the planning will be carried out into the operating room using 3D printed predictive holes surgical guides to determine accurately the optimum position of customized plates |
|
| control group | Active Comparator | patients in this group will be treated using a conventional protocol of reduction depending on visualization intraoperative and tactile sensation and will be fixed using a stock miniplates and screws. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduction and fixation of zygomatico- Maxillary complex fracture using a full digital work flow | Procedure | All surgeries will be carried out under general anesthesia the fracture lines will be exposed then For the study group: following the exposure of all fracture lines , anatomically seated bone-supported predictive holes surgical guides will be inserted on the bone segments with intimate contact. Each segment hole will be drilled according to the predesigned predictive holes guide. The fractured segments will then be reduced and fixed using titanium miniplates customized for the patient and screws at least two screws for each fracture segment. then closure in layers will be performed using absorbable vicryl for deep layers and intraoral sutures and non-absorbable polyproline for skin closure. |
| Measure | Description | Time Frame |
|---|---|---|
| Zygomatic reposition | the accuracy of zygomatic bone reduction and fixation using postoperative CT scan | immediate postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| intraoperative time | duration of operation using stopwatch | during the operation |
| paresthesia | sensation in the area supplied by the infraorbital nerve using a 2 points discrimination test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dina Ayman Fayek, M.Sc | Assistant lecturer oral and maxillofacial surgery department Future university in Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo university | Giza | 12613 | Egypt |
the data will be available from the corresponding author upon reasonable request.
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| Reduction and fixation of zygomatico- maxillary complex fracture using a conventional free hand protocol | Procedure | For the control group: all cases will be treated under general anesthesia and the fracture lines will be exposed then the conventional protocol of treatment depend mainly on visualization of the fracture line and tactile sensation of the operator intra-operative during reduction procedure and the fixation of fractured segments will be done using titanium miniplates and screws then closure in layers will be performed. |
|
| pre operative, immediate postoperative and 6 months post operative |
| patient satisfaction | patient aesthetic satisfaction will be measured using a visual analogue scale from 0 to 10 in a questionnaire form, zero mean not satisfied at all and 10 is the maximum satisfaction. | 6 months postoperative |
| ID | Term |
|---|---|
| D015051 | Zygomatic Fractures |
| ID | Term |
|---|---|
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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