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

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ClinicalTrials.gov Identifier: NCT03530891
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Kadry, Cairo University

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

Condition or disease Intervention/treatment Phase
Mandible Fracture Procedure: Computer guided lag screw fixation Procedure: Conventional lag screw fixation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Masking Description: Because the two interventions requires different pre operative preparation, both the participants and investigators can't be blinded.
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Computer Guided Lag Screw Fixation in Comparison to Conventional Lag Screw Fixation in Anterior Mandibular Fractures (RCT)
Actual Study Start Date : January 11, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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.
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.
Other Name: computer assisted surgery

Active Comparator: Conventional lag screw fixation
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.
Other Name: traditional lag screw fixation




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03530891


Contacts
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Contact: Mohamed N Kadry, MSc +201200560027 m.kadry2011@gmail.com

Locations
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Egypt
Faculty of Oral and Dental Medicine - Cairo University Recruiting
Giza, Egypt, 12613
Contact: Mohamed N Kadry, MsC    +201200560027    m.Kadry2011@gmail.com   
Contact: Khaled S Amr, PHD    +201006029031    khaledamr82@hotmail.com   
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Khaled S Amr, PhD Faculty of oral and dental medicine, Cairo University.

Publications:

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Responsible Party: Mohamed Kadry, Assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT03530891     History of Changes
Other Study ID Numbers: CEBD-CU-2018-5-4
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mohamed Kadry, Cairo University:
anterior mandible fracture
surgery computer assisted

Additional relevant MeSH terms:
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Fractures, Bone
Mandibular Fractures
Wounds and Injuries
Jaw Fractures
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Skull Fractures