NCT03530891

Computer Guided Lag Screw Fixation Versus Conventional Lag Screw Fixation in Anterior Mandibular Fractures

Evaluation of the Efficacy of Computer Guided Lag Screw Fixation in Comparison to Conventional Lag Screw Fixation in Anterior Mandibular Fractures (RCT)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Comparison between computer guided lag screw fixation versus traditional lag screw fixation in open reduction and internal fixation of anterior mandibular fractures.

Detailed description

Two groups of patients with anterior mandibular fractures indicated for open reduction and internal fixation. First group will be subjected to computer guided lag screw fixation. Second group will be subjected to traditional lag screw fixation. Eligible patients will be randomised in equal proportions between study group (computer guided lag screw fixation) and control group (conventional lag screw fixation). A- Computer guided lag screw fixation group: * Pre operative Computed tomography will be done for the patient. * Computed tomography data will be imported into Computer aided surgical simulation software. * Utilizing Computer aided surgical simulation software the fracture segments are virtually reduced and patient specific surgical guide is designed and sent to three dimension printer before operation. * Intra operative: All cases will undergo surgery under general anaesthesia. * Exposure of the fractured segments will be done using vestibular incision. * Inter-maxillary fixation will be done * The fractured segments will be reduced in normal anatomic position guided by occlusion. * Fracture fragments will be fixed using lag screws utilizing patient specific surgical guide. * Closure of the surgical incision. * Post operative at first week Computed tomography will be done for the patient. * Computed tomography data will be imported into computer aided surgical simulation software. * Utilizing computer aided surgical simulation software the post operative computed tomography will be superimposed onto the pre operative planned simulation. B- Conventional titanium plates: * Pre operative Computed tomography will be done for the patient. * Computed tomography data will be imported into Computer aided surgical simulation software. * Utilizing Computer aided surgical simulation software the fracture segments are virtually reduced. * Intra operative: All cases will undergo surgery under general anaesthesia. * Exposure of the fractured segments will be done using vestibular incision. * Inter-maxillary fixation will be done. * The fractured segments will be reduced in normal anatomic position guided by occlusion. * The fracture fragments will be fixed using lag screws. * Closure of the surgical incision. * Post operative at first week Computed tomography will be done for the patient. * Computed tomography data will be imported into computer aided surgical simulation software. * Utilizing computer aided surgical simulation software the post operative computed tomography will be superimposed onto the pre operative planned simulation. Follow up for both groups: Clinical evaluation will be performed at first week postoperative then patients will be recalled every week for one month. Final follow up visit will be at 3 months post operative.

Conditions

• Mandible Fracture

Interventions

Type	Name	Description
PROCEDURE	Computer guided lag screw fixation	Under general anaesthesia: Patient specific pre operative prefabricated surgical guide will be used intra operative for open reduction and internal fixation for anterior mandibular fracture using lag screws.
PROCEDURE	Conventional lag screw fixation	Under general anaesthesia: Open reduction and internal fixation for anterior mandibular fracture utilising lag screws.

Timeline

• Start date: 2018-01-11
• Primary completion: 2019-03-01
• Completion: 2019-06-01
• First posted: 2018-05-21
• Last updated: 2018-05-21

Locations

1 site across 1 country: Egypt