Combined Posterior and Anterior Ring Fixation Versus Posterior Ring Fixation Alone in Management of Unstable Tile B2 and C1 Pelvic Ring Injuries: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Rate of Excellent, Good, or Fair Clinical Outcomes
研究概览
简要总结
The aim for surgical treatment of unstable Tile B2 & C1 pelvic ring injuries is an anatomical reduction to allow early weight-bearing, pain relief and to prevent future pelvic asymmetry. So, we usually used combined posterior & anterior ring fixation, relying on the fact that anterior pelvic ring adequate reduction and fixation better augment posterior ring fixation and enhance overall pelvic stability. However, anterior ring fixation requires a second incision with a longer operation time and more blood loss. The main disadvantage of the second incision is the higher risk of wound infection, either superficial or deep, which questions its necessity and raises concerns about the possibility of isolated posterior ring fixation in managing Tile B2 & C1 pelvic ring injuries with good outcomes.
The fundamental algorithm was the questionable need for additional anterior ring fixation in managing Tile B2 and C1 pelvic ring injuries combined with posterior ring fixation, whether the incidence of postoperative complications, radiological and clinical outcomes differed between these two groups. After reviewing the literature, we found a lack of knowledge in the prospective assessment of such outcomes between the two fixation groups. So, This RCT aims to reach a satisfactory result and prove or deny the questionable need for anterior ring fixation in managing Tile B2 and C1 pelvic ring injuries. Our hypothesis was that PR fixation is at least as good as APR fixation.
详细描述
Type of Study: Prospective randomized controlled clinical trial Randomization technique: Block Randomization. Study Setting: The operations were held in Ain Shams university hospitals. Study Period: From 2019 till 2020.
Study Population:
Inclusion Criteria:
Tile B2 and C1 pelvic ring injuries Nakatani zone II pubic rami fractures with intact inguinal ligament Age between 16-60 years old Recent pelvic ring injuries less than three weeks
Exclusion Criteria:
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
- 否
入选标准
- •Tile B2 and C1 pelvic ring injuries
- •Nakatani zone II pubic rami fractures with intact inguinal ligament
- •Age between 16-60 years old
- •recent pelvic ring injuries less than three weeks
排除标准
- •Tile A pelvic ring injuries
- •Nakatani zone I & III pubic rami fractures
- •neglected pelvic ring injuries exceeding three weeks
- •Age less than 16 years and older than 60 years
结局指标
主要结局
Rate of Excellent, Good, or Fair Clinical Outcomes
时间窗: one 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 Outcomes
时间窗: one 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).
Postoperative Complications' Rate
时间窗: Through study completion, an average of 1 year postoperative
We focused the evaluation of Postoperative complications on the local complications related to fixation principles and technique rather than general complications related to the patient status and associated injuries: LLD, foot drop, SI screw cut out, wound infection, residual malunion or non-union of the anterior or posterior ring, and loss of reduction (2ry SI dislocation or any rotational or vertical re-displacement that exceeds 2 cm or posterior sacral fracture gap that exceeds 1 cm)
次要结局
- Number of participants Able To Weight-bear Postoperative(Up to one year postoperative)
- Rate of Anatomical, Acceptable, or Non-anatomic Intraoperative Assessment of Reduction(It was performed intraoperative)
- Mean Intraoperative Blood Loss(Up to 4 days postoperative)
- Number of participants that required IV Opiods as an Analgesia(up to 4 days postoperative)
- Mean Operative Time(It was calculated intra-operative)
- Need For Another Operations' Rate(Through study completion, an average of 1 year postoperative)
- The Average Length OF Hospital Stay(Up to 4 days postoperative)
研究者
Islam Moussa
Assistant lecturer of orthopedic surgery
Ain Shams University