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临床试验/NCT06011122
NCT06011122已完成不适用

Analysis of Implant Placement of Patients With Distal Radius Fractures in Western Britain,

University Hospital, Brest5 个研究点 分布在 1 个国家目标入组 2,723 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,723
试验地点
5
主要终点
Influence of plate design on positioning

研究概览

简要总结

The purpose of this study was to determine the impact of design on plate position at the level of the distal radius. Six anterior wrist plates design were analyzed relative to the watershed line using the Soong classification. A total of 2723 anterior locking plate fixation cases were analyzed and divided into six groups: Zimmer Biomet, Newclip Technics, Stryker, Synthes, Medartis and Medartis Footprint. The number of plates recorded as Soong grade 0+1 was determined for each design, then compared using the Marascuilo procedure. The Zimmer Biomet and Newclip plates were proximal to the Watershed line significantly more often than those by Synthes and Medartis Footprint. Plate position with the Medartis design was significantly more proximal to the Watershed line compared to its companion design, the Medartis Footprint plate. Plate design is a deciding factor when treating distal radial fractures, to avoid impingement when implant removal is not routinely planned.

详细描述

This is a retrospective multicenter study involving several orthopedic surgeons with a trauma surgery practice within the public hospital centers of the department of Finistère. These include the CHU de Brest - Brest University Hospital Center (La Cavale Blanche), the HIA Clermont-Tonnerre military hospital (Hôpital d'Instruction des Armées - Armed Forces Teaching Hospital), the CH des Pays de Morlaix, the CH de Landerneau Ferdinand Grall, the CH de Carhaix and the CH de Cornouaille Quimper Concarneau. This study was approved by the local ethics committee. Among the cited hospital centers, the CHU de Brest is a level 1 trauma center, the CH des pays de Morlaix, the HIA military hospital and the CH de Cornouaille are level 2 trauma centers and the CH de Landerneau and Carhaix are level 3 trauma centers.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
14 Years 至 102 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Influence of plate design on positioning

时间窗: Retrospective study on Xray during 45 days

The primary aim of this study was to compare six different VLPs meant to be positioned proximal to the watershed line, using the Soong classification. We will assess the rate of plates positioned "Soong 0+1" for each plate design

次要结局

  • Epidemiology(Retrospective study on Xray during 45 days)
  • Impact of fracture type on plate positioning(Retrospective study on Xray during 45 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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