Erich Arch Bars vs. IMF Screws for Placement of Maxillomandibular Fixation: Which is More Time Effective in the Operating Room Setting?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- Time
研究概览
简要总结
Determining the cost effectiveness, based on the time duration of application, of two methods of wiring the jaws together during surgery to repair mandible fractures. One technique is more expensive but faster in application, while the other is less expensive and takes more time to apply.
详细描述
Purpose:
To identify which option of wiring the jaws together during treatment of mandible fractures is more cost effective to the patient, Erich arch bars or IMF (Intermaxillary Fixation) screws. Patients who sustain mandible fractures that meet the inclusion criteria will be randomized to one of the two treatment types listed above. The overall treatment in both categories is consistent with the standard of care, the only difference being the method utilized to achieve intermaxillary fixation during the course of the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-70
- •Patients with no greater than one (1) open fracture of the tooth-bearing mandible
- •Mandibular angle fractures ± Ramus or subcondylar fracture
- •Body/symphysis ± subcondylar
- •Isolated angle fracture
- •Isolate subcondylar fractures
- •Bilateral subcondylar fractures
- •Any condylar head/neck fracture requiring treatment
- •Patients who are candidates for treatment of their fractures in the operating room setting
排除标准
- •Patients younger than 18 or older than 70
- •Patients with developing tooth buds anterior to the second molars
- •Patients with inadequate stability of occlusion
- •Edentulism
- •Unstable vertical and horizontal stops to the occlusion
- •Patients with disorders affecting bone healing, metabolism and turnover
- •Those patients on bisphosphonates, oral or IV
- •Patients with evidence of intrabony pathology of the mandible or maxilla
- •The presence of any of the following:
- •Greater than one (1) open fracture of the tooth-bearing mandible
- •Bilateral angle fractures are exempt from this
- •Comminuted fractures of the mandible
- •Concomitant infection, or osteomyelitis of the mandible
- •Mechanism of injury
- •Pathologic fracture
- •Gun-shot wounds
结局指标
主要结局
Time
时间窗: Time duration of placement of device in operating room
Time duration for the application of device, in minutes.
次要结局
未报告次要终点
研究者
Daniel Meara
Oral and Maxillofacial Surgery Resident
Christiana Care Health Services