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

Cairo University (CU)

Status: Active, not recruiting

Conditions: Zygomatic Fractures

Treatments: Procedure: Reduction and fixation of zygomatico- maxillary complex fracture using a conventional free hand protocol; Procedure: Reduction and fixation of zygomatico- Maxillary complex fracture using a full digital work flow

Study type: Interventional

Funder types: Other

Identifiers

NCT06588075

OMFS 3319

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups

study group

Experimental group

Description:

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

Treatment:

Procedure: Reduction and fixation of zygomatico- Maxillary complex fracture using a full digital work flow

control group

Active Comparator group

Description:

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.

Treatment:

Procedure: Reduction and fixation of zygomatico- maxillary complex fracture using a conventional free hand protocol