In-person Randomized Control Trial of the Incidence of Postoperative Hypoesthesia Among Bilateral Sagittal Split Osteotomy Patients Treated With Ultrasonic vs. Reciprocating Saw Instrumentation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Postoperative Hypoesthesia Experienced at 3months
研究概览
简要总结
The aim of this prospective study is to analyze the postoperative paresthesias experienced in patients who undergo bilateral sagittal split osteotomies (BSSO) using an ultrasonic saw, versus a reciprocating saw. Patients included in the study are ages 15-45 scheduled to undergo BSSO surgery at the University of California, San Francisco. One side of the patient's mandible will be instrumented with either the Stryker Sonopet ultrasonic saw or traditional reciprocating saw, while the other side will receive the remaining intervention (determined via randomization on the day of surgery). Patient paresthesias will then be analyzed on each side for 3 months postoperatively (at postoperative days: 1, 7, 14, 28, and 84). Sensory examinations will be carried out by blinded examiners using von Frey hairs and two point discrimination testing. Patients will also subjectively rate their sensation on each side. The results will then be analyzed to determine if patient paresthesias, including the severity and duration, differed depending on which instrument was used, the ultrasonic or reciprocating saw.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients and providers assessing postoperative nerve functioning are blinded to which side of the mandible received which intervention
入排标准
- 年龄范围
- — 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be undergoing bilateral sagittal split osteotomy surgery with Dr. Saghezchi at UCSF
- •Must agree to return for all follow up visits.
- •Must not have any preexisting V3 nerve paresthesia
- •Must be below the age of 45.
排除标准
- •Persons with preexisting V3 nerve paresthesias
- •Pre-pubertal children will be excluded (per routine practice for this type of surgery).
- •Patients with syndromic genetic conditions that demonstrate clearly different anatomy in the two sides of their jaws will be excluded since the two sides may not be "exchangeable".
结局指标
主要结局
Postoperative Hypoesthesia Experienced at 3months
时间窗: Within 15 days of exact 3 months post-operation
Count of patient mandibles who exhibited \*\*any\*\* hypoesthesia at 3months post-operation (i.e. VFH does not equal 0.008g). VFH filaments measure the minimum weight which a dermatome in question can sense. In this study, the measurements were designed to have the following range: 0.008g, 0.02g, 0.04g, 0.07g, 0.16g, 0.4g, 0.6g, 1g, 1.4g, 2g, 4g, 6g, 8g, 10g, 15g, with 0.008g being no neurosensory deficit. Although 28 persons completed the study, only 21 patients presented for their 3 month followup time, which was defined as with-in 15 days of 90th day after operation. Therefore, the denominator for this outcome is 21, for each intervention arm. The numerator is the number of Left or Right chin areas that exhibited less than "normal" sensation.
次要结局
- Unfavorable Fracture(This outcome occurs during the surgery. It was measured on the same day.)