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NCT Number: NCT06588075

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

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.

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Key information

Conditions

Zygomatic Fractures Craniocerebral Trauma Facial Injuries Fractures, Bone Maxillofacial Injuries Nervous System Diseases Skull Fractures Trauma, Nervous System Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo university

Giza, 12613, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Zygomatic reposition

    Time frame: immediate postoperative

    the accuracy of zygomatic bone reduction and fixation using postoperative CT scan

Secondary outcomes

  1. intraoperative time

    Time frame: during the operation

    duration of operation using stopwatch

  2. paresthesia

    Time frame: pre operative, immediate postoperative and 6 months post operative

    sensation in the area supplied by the infraorbital nerve using a 2 points discrimination test

  3. patient satisfaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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