NCT06588075

A Full Digital VS Conventional Protocol in Management of Zygomatico-Maxillary Complex Fracture

Evaluation of the Accuracy of Zygomatico-Maxillary Complex Fracture Reduction And Fixation Using A Full Digital Workflow Versus Conventional Protocol: A Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Zygomatic Fractures

Interventions

Type	Name	Description
PROCEDURE	Reduction and fixation of zygomatico- Maxillary complex fracture using a full digital work flow	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.
PROCEDURE	Reduction and fixation of zygomatico- maxillary complex fracture using a conventional free hand protocol	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.

Timeline

• Start date: 2024-09-04
• Primary completion: 2025-06-01
• Completion: 2026-01-01
• First posted: 2024-09-19
• Last updated: 2026-02-18

Locations

1 site across 1 country: Egypt