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临床试验/NCT02327949
NCT02327949Unknown4 期

Prospective Comparison Between W-Shaped Acetabular Angular Plate (WAAP) and Reconstruction Plate for the Treatment of Posterior Acetabular Wall Fracture

Hebei Medical University Third Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年12月1日最近更新:
适应症
干预措施

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

Experimental

WP group:treated with W-Shaped Angular Plate

干预措施: W-Shaped Angular Plate (Device)

RP group

Active Comparator

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

发起方
Hebei Medical University Third Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhiyong Hou

Deputy Director of Orthopaedic Center,MD

Hebei Medical University Third Hospital

研究点 (1)

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