Comparison of Herbert cannulated bone screw (HBS 2) with miniplates for the osteosynthesis of the anterior mandibular fracture: An Exploratory randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- to compare stability of the osteosynthesis by evaluating inter-fragmentary mobility, which will be done by bimanual palpation
研究概览
简要总结
Though literature demonstrates wide variety of internal fixation choices for anterior mandibular fractures, however, there is no sufficient evidence about the superiority of HBS screw over the standard miniplate fixation. Also, none of the studies had similar dimensions of the HBS screw. Also, none of the studies defined the length of the proximal and distal threads of HBS screws. Furthermore, some of the studies did not mention whether they used single or double HBS screws in anterior mandible fixation; and other studies either utilized one or two HBS screws. Also, the number of the holes in minplate fixation was not defined in many studies. None of the studies in literature could be found comparing two different dimensions of HBS screws in view of their outcomes. Hence this study aims to eliminate all the limitations found in literature, along with evaluating and standardizing the most suitable dimensions of the HBS screw, along with standardizing the manufacturer. Furthermore, it aims to compare the outcomes with the standard miniplate fixation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients presenting with anterior mandibular fractures (symphysis or parasymphysis fracture mandible) Patients with anterior mandibular fractures (symphysis or parasymphysis fracture mandible), associated with additional maxillary or other associated facial fractures will also be included, unless anterior mandible requires reconstruction plate fixation Age >18 and less than 50 years Patients presenting within one week of fracture incident.
排除标准
- •Patients with age of 18 years or less; or more than 50 years Communited anterior mandibular fractures requiring obvious management with reconstruction plating Patients with active infection (pus) at the site of fracture Patients with bone loss at the site of fracture Mal-united fractures or fractures presenting more than 1 week late Edentulous patients requiring reconstruction plate Patient with medical co-morbidities like neurological disorders or low GCS (Glasgow Coma Scale); spine/cervical injuries; uncontrolled diabetes; uncontrolled hypertension, cardio-vascular disorders, bleeding disorders: which contra-indicate surgical management.
- •Patient with known cancer or undergoing/having history of radio-therapy/chemo-therapy.
- •Patient who are active smokers/alcoholic Pregnant patient Patients lost to follow up.
结局指标
主要结局
to compare stability of the osteosynthesis by evaluating inter-fragmentary mobility, which will be done by bimanual palpation
时间窗: 3 weeks, 6 weeks, 3 months, 6 months
次要结局
- Post-operative occlusion(3 weeks, 6 weeks, 3 months, 6 months)
- Post-operative infection (edema or pus at the post-operative site)(3 weeks, 6 weeks, 3 months, 6 months)
- Post-operative nerve paraesthesia (using two-point discrimination)(3 weeks, 6 weeks, 3 months, 6 months)
- Hardware fracture(3 weeks, 6 weeks, 3 months, 6 months)
- Hardware loosening(3 weeks, 6 weeks, 3 months, 6 months)
- Time taken for the procedure(after exposure of fracture site till completion of osteosynthesis i.e intra-operatively)
- Pain score (Visual analogue scale: VAS score)(3 weeks, 6 weeks, 3 months, 6 months)