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

Not Applicable

Active, not recruiting

• Conditions: Zygomatic Fractures
• Interventions: Procedure: Reduction and fixation of zygomatico- Maxillary complex fracture using a full digital work flow; Procedure: Reduction and fixation of zygomatico- maxillary complex fracture using a conventional free hand protocol

• Registration Number: NCT06588075
• Lead Sponsor: Cairo University

Brief 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.

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-04
• Study First Submitted: 2024-09-05
• Study First Submitted QC: 2024-09-06
• Study First Posted: 2024-09-09
• Last Update Submitted: 2024-09-15
• Last Update Posted: 2024-09-19
• Primary Completion: 2026-03-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Zygomatic Fracture Types III, IV, V, VII, and VIII according to Rowe and Killey's classification.
• Age range (18-60 years).
• Patients are willing for the surgical procedure and follow-up, with informed consent

Exclusion Criteria

• Zygomatic Fracture Type I, II according to Rowe and Killey's classification.
• Patients with contraindications for general anesthesia.
• Patient on radiotherapy.
• Patients suffer from bone disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	Reduction and fixation of zygomatico- Maxillary complex fracture using a full digital work flow	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	Reduction and fixation of zygomatico- maxillary complex fracture using a conventional free hand protocol	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.

Primary Outcome Measures

Name	Time	Method
Zygomatic reposition	immediate postoperative	the accuracy of zygomatic bone reduction and fixation using postoperative CT scan

Secondary Outcome Measures

Name	Time	Method
intraoperative time	during the operation	duration of operation using stopwatch
paresthesia	pre operative, immediate postoperative and 6 months post operative	sensation in the area supplied by the infraorbital nerve using a 2 points discrimination test
patient satisfaction	6 months postoperative	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.

Trial Locations

Locations (1)

Cairo university; 🇪🇬 Giza, Egypt