Computer Guided Lag Screw Fixation Versus Conventional Lag Screw Fixation in Anterior Mandibular Fractures
May 18, 2018 updated by: Mohamed Kadry, Cairo University
Evaluation of the Efficacy of Computer Guided Lag Screw Fixation in Comparison to Conventional Lag Screw Fixation in Anterior Mandibular Fractures (RCT)
Comparison between computer guided lag screw fixation versus traditional lag screw fixation in open reduction and internal fixation of anterior mandibular fractures.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Giza, Egypt, 12613
- Recruiting
- Faculty of oral and dental medicine - cairo university
-
Contact:
- Mohamed N Kadry, MsC
- Phone Number: +201200560027
- Email: m.Kadry2011@gmail.com
-
Contact:
- Khaled S Amr, PHD
- Phone Number: +201006029031
- Email: khaledamr82@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Computer guided lag screw fixation
Patient specific surgical guided will be used for open reduction and internal fixation for anterior mandibular fracture by lag screws.
|
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.
Other Names:
|
|
Active Comparator: Conventional lag screw fixation
Open reduction and internal fixation for anterior mandibular fracture using lag screws.
|
Under general anaesthesia: Open reduction and internal fixation for anterior mandibular fracture utilising lag screws.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stability of fixed fractured segment
Time Frame: 1st week post operative.
|
stability of fixed fractured segment will be assessed using measuring device bimanual manipulation, measuring unit (binary yes or no)
|
1st week post operative.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
neurosensory disturbance
Time Frame: one month post operative
|
presence of neurosensory disturbance will be assessed using measuring device: subjective assessment, measuring unit (binary yes or no)
|
one month post operative
|
|
Accuracy of lag screw placement
Time Frame: 1st week post operative.
|
Accuracy of lag screw placement will be assessed by measuring device: Computer aided surgical simulation (CASS) software, measuring unit: Millimetre
|
1st week post operative.
|
|
supplemental fixation devices
Time Frame: intra operative and one month post operative
|
The need for intra operative or post operative supplemental fixation devices, measuring device clinical assessment.
measuring unit: binary yes or no
|
intra operative and one month post operative
|
|
Need for second surgery
Time Frame: one month post operative
|
The need for second surgical procedure will be assessed by clinical assessment (measuring device).
measuring unit: binary (yes or no).
|
one month post operative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Khaled S Amr, PhD, Faculty of oral and dental medicine, Cairo University.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Ellis E 3rd. Is lag screw fixation superior to plate fixation to treat fractures of the mandibular symphysis? J Oral Maxillofac Surg. 2012 Apr;70(4):875-82. doi: 10.1016/j.joms.2011.08.042. Epub 2011 Dec 30.
- Kallela I, Ilzuka T, Laine P, Lindqvist C. Lag-screw fixation of mandibular parasymphyseal and angle fractures. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996 Nov;82(5):510-6. doi: 10.1016/s1079-2104(96)80195-8.
- 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.
- Zachariades N, Mezitis M, Papademetriou I. Use of lag screws for the management of mandibular trauma. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996 Feb;81(2):164-7. doi: 10.1016/s1079-2104(96)80407-0.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 11, 2018
Primary Completion (Anticipated)
March 1, 2019
Study Completion (Anticipated)
June 1, 2019
Study Registration Dates
First Submitted
May 4, 2018
First Submitted That Met QC Criteria
May 18, 2018
First Posted (Actual)
May 21, 2018
Study Record Updates
Last Update Posted (Actual)
May 21, 2018
Last Update Submitted That Met QC Criteria
May 18, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEBD-CU-2018-5-4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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