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

NCT ID: NCT06588075

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-04
• Study Completion Date: 2026-04-01

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.

Conditions

Zygomatic Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

study group

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

control group

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Dina Ayman Fayek

Assistant lecturer in Oral and Maxillofacial department in Future university in Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dina Ayman Fayek, M.Sc

Role: PRINCIPAL_INVESTIGATOR

Assistant lecturer oral and maxillofacial surgery department Future university in Egypt

Locations

Cairo university

Giza, , Egypt

Countries

Egypt

Other Identifiers

OMFS 3319

Identifier Type: -

Identifier Source: org_study_id