Single Versus Double Symphyseal Plating in Management of Vertically Unstable Open Book Pelvic Ring Injuries: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Rate of recurrent diastasis
研究概览
简要总结
compare functional, radiological outcomes, implant failure and the incidence of recurrent diastasis of single superior symphyseal plate versus double plating in management of vertically unstable open book injuries
详细描述
The real algorithm was the necessity for double superior & anterior plating versus single superior symphyseal plate in management of APC III pelvic ring injuries, whether the incidence of intraoperative and short-term postoperative complications, recurrent diastasis, radiological and functional outcomes differed between these two methods. Our hypothesis was that the use of an additional anterior symphyseal plating could provide a more rigid fixation, with less complications of recurrent diastasis or implant failure. Also it will be applied through the same incision without increasing the patient overall morbidity.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Patients and physicians allocated to each intervention group were aware of the allocation; however, the data analysts and the outcome assessors were kept blinded to the allocation.
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Anterior ring symphyses diastasis
- •Tile C pelvic ring injuries
- •Age between 16-60 years' old
排除标准
- •Tile B pelvic ring injuries
- •Isolated bony fractures of the anterior pelvic ring
- •Open fractures
- •Age less than 14 years and older than 60 years
- •Associated internal organ injuries that require definitive intervention
研究组 & 干预措施
single superior symphyseal plate
15 cases undergoing single superior symphyseal plate, reduction of the posterior ring was either closed reduction in SI joint dislocations & fracture-dislocations and sacral fractures or open reduction in iliac wing fractures through the lateral window of the ilioinguinal approach.Anterior pelvic ring reduction and fixation was done via the classic Pfannenstiel approach
干预措施: single symphyseal plating in management of vertically unsable open book pelvic ring injuries (Procedure)
double superior & anterior symphyseal plates
15 cases undergoing double superior & anterior symphyseal plates, 15 cases undergoing double superior & anterior symphyseal plates, reduction of the posterior ring was either closed reduction in SI joint dislocations & fracture-dislocations and sacral fractures or open reduction in iliac wing fractures through the lateral window of the ilioinguinal approach.Anterior pelvic ring reduction and fixation was done via the classic Pfannenstiel approach
干预措施: single symphyseal plating in management of vertically unsable open book pelvic ring injuries (Procedure)
结局指标
主要结局
Rate of recurrent diastasis
时间窗: throughout study completion, average one year postoperative
rate of symphyseal translation was measured \& compared between the two study groups
Rate of Excellent, Good, Fair or Poor clinical outcome
时间窗: 1 year postoperative
clinical assessment by Majeed pelvic scoring system evaluated and calculated at each follow-up visit with the mean value presented
Rate of Excellent, Good, Fair or Poor radiological outcome
时间窗: 1 year postoperative
Radiological assessment using Matta \& Tornetta radiological principles via plain x-ray pelvis showing both hips: anteroposterior, inlet and outlet views \& CT pelvis if available; we evaluated five criteria on X-ray films postoperatively: residual posterior displacement, vertical displacement, pubic symphyseal translation, sagittal rotation, and gapping of the sacroiliac joint; according to the grading of Matta and Tornetta, we classified the results into Excellent (less than or equal 4 mm), Good (4-10 mm), Fair (10-20 mm), and Poor (more than 20 mm).
次要结局
- Mean intraoperative blood loss(up to 5 days post-operative)
- Mean operative time(It was calculated intra-operative)
- postoperative complications' rate(1 year post-operative)
研究者
Islam Moussa
lecturer of orthopedic surgery
Ain Shams University