Clinical trial NCT03530891: Computer Guided Lag Screw Fixation Versus Conventional Lag Screw Fixation in Anterior Mandibular Fractures
Official title: Evaluation of the Efficacy of Computer Guided Lag Screw Fixation in Comparison to Conventional Lag Screw Fixation in Anterior Mandibular Fractures (RCT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mandible Fracture
Keywords: anterior mandible fracture
surgery computer assisted
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * A Randomized clinical trial.
* Parallel group study.
* A trial will be carried out in hospital of Oral and Maxillofacial surgery department- Faculty of Oral and Dental Medicine Cairo University
* Equal randomization: participants with equal probabilities for intervention.
* Positive controlled: Both groups receiving treatment.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion criteria:

* Patients with anterior mandibular fracture indicated for open reduction internal fixation alone or in combination with fracture elsewhere in the mandible or mid face.
* All ages and both sexes were included in this study.
* Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
* Patients with good general condition allowing major surgical procedure under general anaesthesia .
* Patients with physical and psychological tolerance.

Exclusion criteria:

* Patients with comminuted fractures as it is not indicated for compression osteosynthesis like lag screws.
* Patients with high risk systemic diseases like uncontrolled diabetes mellitus. As uncontrolled diabetes mellitus has a negative impact on normal bone healing.
* Patients with old and/or mal-union fractures. As they will affect accuracy of reduction of the fractured segments.

Primary outcomes:
measure: Stability of fixed fractured segment
timeFrame: 1st week post operative.
Secondary outcomes:
measure: neurosensory disturbance
timeFrame: one month post operative
measure: Accuracy of lag screw placement
timeFrame: 1st week post operative.
measure: supplemental fixation devices
timeFrame: intra operative and one month post operative
measure: Need for second surgery
timeFrame: one month post operative
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Oral and Dental Medicine - Cairo University
Study officials:
affiliation: Faculty of oral and dental medicine, Cairo University.
name: Khaled S Amr, PhD
role: STUDY_DIRECTOR
References:
citation: Ellis E 3rd, Ghali GE. Lag screw fixation of anterior mandibular fractures. J Oral Maxillofac Surg. 1991 Jan;49(1):13-21; discussion 21-2. doi: 10.1016/0278-2391(91)90259-o.
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citation: Xia JJ, Gateno J, Teichgraeber JF, Christensen AM, Lasky RE, Lemoine JJ, Liebschner MA. Accuracy of the computer-aided surgical simulation (CASS) system in the treatment of patients with complex craniomaxillofacial deformity: A pilot study. J Oral Maxillofac Surg. 2007 Feb;65(2):248-54. doi: 10.1016/j.joms.2006.10.005.
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citation: Tiwana PS, Kushner GM, Alpert B. Lag screw fixation of anterior mandibular fractures: a retrospective analysis of intraoperative and postoperative complications. J Oral Maxillofac Surg. 2007 Jun;65(6):1180-5. doi: 10.1016/j.joms.2006.11.046.
citation: Jones JK, Van Sickels JE. Rigid fixation: a review of concepts and treatment of fractures. Oral Surg Oral Med Oral Pathol. 1988 Jan;65(1):13-8. doi: 10.1016/0030-4220(88)90183-1.
citation: Retzepi M, Donos N. The effect of diabetes mellitus on osseous healing. Clin Oral Implants Res. 2010 Jul;21(7):673-81. doi: 10.1111/j.1600-0501.2010.01923.x. Epub 2010 May 3.
citation: Parashar A, Sharma RK. Unfavourable outcomes in maxillofacial injuries: How to avoid and manage. Indian J Plast Surg. 2013 May;46(2):221-34. doi: 10.4103/0970-0358.118597.