Prospective Comparison Between W-Shaped Acetabular Angular Plate (WAAP) and Reconstruction Plate for the Treatment of Posterior Acetabular Wall Fracture
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction quality of fracture
研究概览
简要总结
The purpose of this study is to determine whether this new W-Shaped Angular Plate is more effective and more safe to operate than the traditional reconstruction plate in the treatment of the posterior wall fracture of acetabulum.
详细描述
The posterior acetabular wall fracture is one of the simpler acetabular fracture patterns and the most common type, accounting for approximately one quarter of all acetabular fractures. Most patients achieve excellent outcomes after anatomical reduction and rigid internal fixation with standard screws and buttress plates.However,it is well known that the reconstruction plate need remould in the surgery. So it does not only lead to the extension of operation time, but also cause poor attach of acetabular posterior wall. Moreover, the angulation of the screw placement for the holes of the reconstruction plate in the danger zone was determined with only caution. The intraoperative fluoroscopy was employed frequently to help determine the periacetabular screw location. If the operator lack of experience, intraarticular screw penetration and prolonged operative duration is inevitable. The investigators now introduce a new type of internal fixation device of acetabular posterior wall fracture that improve the shortcomings of existing technology.The plate itself can be thought to consist of three regions: the iliac region, the danger zone region, and the ischial tuberosity region. The organization of these regions causes the plate to resemble the English alphabet letter ''W''.The contour and zygomorphy of the W-shaped plate matched the surface of the posterior column of the acetabulum. There are two rows of drill holes in the danger zone region. A special safe-angled drilling guide was used to assist in the operation. A retrospective study has been indicated that this kind of new plate produce good results. This device may help to avoid intraarticular screw penetration and reduce operative duration and blood loss. The device further provides a stable fixation of the posterior wall that is amenable to early range of motion and weight bearing postoperatively, and results in a good clinical outcome.
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)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 years or older(with no upper age limit)
- •Sustained a posterior acetabular wall fracture(ASIF/OTA classification 62-A1)
- •Operation was performed within 14 days after the fracture occurring
排除标准
- •Presented with a pathologic acetabular fracture
- •Neuropathic arthropathy,dementia and other disease processes which made postoperative compliance unreliable
- •Refused to participate
- •Patients who were unable to walk before injury
研究组 & 干预措施
WP group
WP group:treated with W-Shaped Angular Plate
干预措施: W-Shaped Angular Plate (Device)
RP group
RP group:treated with Reconstruction Plate
干预措施: Reconstruction Plate (Device)
结局指标
主要结局
Reduction quality of fracture
时间窗: Six months
Based on the radiographic grade criteria developed by Matta
次要结局
- Early postoperative complications(One month)
- Late postoperative complications(One year)
- Evaluation of Clinical outcome(One year)
- Surgical details(Intraoperative)
研究者
Zhiyong Hou
Deputy Director of Orthopaedic Center,MD
Hebei Medical University Third Hospital
