Mandible FractureNCT03530891
Computer Guided Lag Screw Fixation Versus Conventional Lag Screw Fixation in Anterior Mandibular Fractures
A study testing Computer guided lag screw fixation and Conventional lag screw fixation in people with Mandible Fracture, run by Cairo University at 1 site in Egypt.
Trial summary
Comparison between computer guided lag screw fixation versus traditional lag screw fixation in open reduction and internal fixation of anterior mandibular fractures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mandible Fracture
- What is being tested?
- Computer guided lag screw fixation and Conventional lag screw fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jan 2018to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Oral and Dental Medicine - Cairo University
Giza, 12613
Mohamed N Kadry, MsC, +201200560027, m.Kadry2011@gmail.com
Khaled S Amr, PHD, +201006029031, khaledamr82@hotmail.com
About this study
Official title: 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.
Read the 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
- Being tested
- Computer guided lag screw fixation, Conventional lag screw fixation
- Keywords
- anterior mandible fracture, surgery computer assisted
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer guided lag screw fixationProcedure or surgery
Also called computer assisted surgery
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.
Conventional lag screw fixationProcedure or surgery
Also called traditional lag screw fixation
Under general anaesthesia: Open reduction and internal fixation for anterior mandibular fracture utilising lag screws.
| Study group | Role | What they receive |
|---|---|---|
| Computer guided lag screw fixation | Experimental | Patient specific surgical guided will be used for open reduction and internal fixation for anterior mandibular fracture by lag screws. Receives: Procedure: Computer guided lag screw fixation |
| Conventional lag screw fixation | Active comparator | Open reduction and internal fixation for anterior mandibular fracture using lag screws. Receives: Procedure: Conventional lag screw fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability of fixed fractured segment
stability of fixed fractured segment will be assessed using measuring device bimanual manipulation, measuring unit (binary yes or no)
Measured: 1st week post operative.
Secondary outcomes (4)
neurosensory disturbance
presence of neurosensory disturbance will be assessed using measuring device: subjective assessment, measuring unit (binary yes or no)
Measured: one month post operative
Accuracy of lag screw placement
Accuracy of lag screw placement will be assessed by measuring device: Computer aided surgical simulation (CASS) software, measuring unit: Millimetre
Measured: 1st week post operative.
supplemental fixation devices
The need for intra operative or post operative supplemental fixation devices, measuring device clinical assessment. measuring unit: binary yes or no
Measured: intra operative and one month post operative
Need for second surgery
The need for second surgical procedure will be assessed by clinical assessment (measuring device). measuring unit: binary (yes or no).
Measured: one month post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start11 Jan 2018
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Mandible FractureStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Kadry, Cairo University
- Investigators
- Khaled S Amr, PhD, Study director, Faculty of oral and dental medicine, Cairo University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530891
- Sponsor's protocol ID
- CEBD-CU-2018-5-4
- Status last verified
- May 2018
- First submitted
- 4 May 2018
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 1985177Ellis 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.
PubMed 22209100Kallela 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.
PubMed 8936514Xia 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.
PubMed 17236929Zachariades 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.
PubMed 8665308Tiwana 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.
PubMed 17517303Jones 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.
PubMed 3277107Retzepi 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.
PubMed 20465554Parashar 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.
PubMed 24501458
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Computer Guided Lag Screw Fixation in Comparison to Conventional Lag Screw Fixation in Anterior Mandibular Fractures (RCT)
- ClinicalTrials.gov ID
- NCT03530891
- Acronym / sponsor ID
- CEBD-CU-2018-5-4
- Conditions
- Mandible Fracture
- Keywords
- anterior mandible fracture, surgery computer assisted
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Computer guided lag screw fixation | Experimental | Procedure: Computer guided lag screw fixationPatient specific surgical guided will be used for open reduction and internal fixation for anterior mandibular fracture by lag screws. |
| Conventional lag screw fixation | Active comparator | Procedure: Conventional lag screw fixationOpen reduction and internal fixation for anterior mandibular fracture using lag screws. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer guided lag screw fixationAlso: computer assisted surgeryUnder 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 or surgery | Computer guided lag screw fixation |
| Conventional lag screw fixationAlso: traditional lag screw fixationUnder general anaesthesia: Open reduction and internal fixation for anterior mandibular fracture utilising lag screws. | Procedure or surgery | Conventional lag screw fixation |
Primary outcome
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)
4 secondary outcomes
neurosensory disturbance
Time frame: one month post operative
Accuracy of lag screw placement
Time frame: 1st week post operative.
supplemental fixation devices
Time frame: intra operative and one month post operative
Need for second surgery
Time frame: one month post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
- Background: PubMed 1985177Ellis 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.
- Background: PubMed 22209100Ellis 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.
- Background: PubMed 8936514Kallela 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.
- Background: PubMed 17236929Xia 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.
- Background: PubMed 8665308Zachariades 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.
- Background: PubMed 17517303Tiwana 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.
- Background: PubMed 3277107Jones 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.
- Background: PubMed 20465554Retzepi 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.
- Background: PubMed 24501458Parashar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khaled S Amr, PhD study director
Faculty of oral and dental medicine, Cairo University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer guided lag screw fixation and Conventional lag screw fixation in people with Mandible Fracture, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed N Kadry, MSc (+201200560027, m.kadry2011@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stability of fixed fractured segment (time frame: 1st week post operative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03530891, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2018.