Supra-Pectineal Quadrilateral Buttress Plating Versus Infra-pectineal Plating in Management of Quadrilateral Plate Fractures: 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
- 2
- 主要终点
- Rate of Excellent, very good, Good, Average or Poor functional outcomes using Modified Merle d'Aubigné scoring system
研究概览
简要总结
The investigators conducted such a prospective randomized controlled study aiming to reach a satisfactory outcome and to compare supra-pectineal QL buttress plating versus infra-pectineal for management of anterior column with or without posterior hemi-transverse component and quadrilateral plate involvement.
详细描述
Our hypothesis was that supra-pectineal quadrilateral buttress plating provides much more rigid fixation and a strong buttress for medial wall migration, also it could correlate with a better functional and radiological outcome. However, there is a lack of knowledge in the prospective assessment of functional and radiological outcomes and follow up of postoperative complications of supra-pectineal quadrilateral buttress plating versus infra-pectineal plating in fixation of QLS and to our knowledge, it will be the first study to include such measures of outcome together in a prospective randomized fashion.
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
- Single (Outcomes Assessor)
盲法说明
Double (Investigator, Outcomes Assessor) 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 column fracture acetabulum with QLS involvement
- •Anterior column posterior hemi-transverse fracture acetabulum with QLS involvement
- •Age between 16-60 years' old
排除标准
- •Open fractures
- •Associated pelvic ring injuries that require intervention
- •Associated internal organ injuries that require intervention
- •Age less than 14 years and older than 60 years
结局指标
主要结局
Rate of Excellent, very good, Good, Average or Poor functional outcomes using Modified Merle d'Aubigné scoring system
时间窗: one-year post-operative
Clinical assessment was done via Modified Merle d'Aubigné scoring system that was calculated at each follow-up visit (out of 18) and presented the mean value; the score evaluates three factors: pain, mobility \& ability to walk. the score maximum being 18 (excellent) and minimum 6 (poor)
Amount of residual displacement
时间窗: immediate post-operative and throughout study completion
Residual displacement was measured in millimeters and compared between the two study groups
Rate of Anatomical, Congruent or Incongruent Radiological Outcomes using Matta & Tornetta radiological principles
时间窗: 1 year postoperative
Radiological assesment was done according to the grading of Matta and Tornetta, The investigators classified the results into: Anatomical, congruent \& incongruent; based on the restoration of the five anatomical lines (iliopectineal line, ilioischial line, acetabular dome, posterior wall \& anterior wall) \& best judged on the anteroposterior view.
次要结局
- Mean intraoperative blood loss(up to 4 days post-operative)
- Mean operative time(it was calculated intra-operative)
- post-operative complications' rate(1-year post-operative)
研究者
Islam Moussa
lecturer of orthopedic surgery
Ain Shams University