Evaluation of the Efficacy of Computer Guided Lag Screw Fixation in Comparison to Conventional Lag Screw Fixation in Anterior Mandibular Fractures (RCT)
试验速览
- 阶段
- 不适用
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Stability of fixed fractured segment
研究概览
简要总结
Comparison between computer guided lag screw fixation versus traditional lag screw fixation in open reduction and internal fixation of anterior mandibular fractures.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Because the two interventions requires different pre operative preparation, both the participants and investigators can't be blinded.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Computer guided lag screw fixation (Procedure)
Conventional lag screw fixation
Open reduction and internal fixation for anterior mandibular fracture using lag screws.
干预措施: Conventional lag screw fixation (Procedure)
结局指标
主要结局
Stability of fixed fractured segment
时间窗: 1st week post operative.
stability of fixed fractured segment will be assessed using measuring device bimanual manipulation, measuring unit (binary yes or no)
次要结局
- Accuracy of lag screw placement(1st week post operative.)
- supplemental fixation devices(intra operative and one month post operative)
- Need for second surgery(one month post operative)
- neurosensory disturbance(one month post operative)
研究者
Mohamed Kadry
Assistant lecturer
Cairo University