跳至主要内容
临床试验/NCT02842684
NCT02842684已完成不适用

Orthopedic Digital Planning for Total Hip Arthroplasties

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年10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
300
试验地点
1
主要终点
postoperative inequality measured on the radiograph the 3rd postoperative day.

研究概览

简要总结

Preoperative planning has been carried out to allow for response preparedness . A layer technique is usually used with standard radiography .The investigators have a record of routine preoperative radiographs by standard recognized as having an advantage over the reproducibility of measurements compared with plain radiography . The Toulouse Hospitals have developed this technology and is part of the routine assessment of hip prothesis pre and postoperatively.

The TraumaCad software can superimpose implants on Picture Archiving and Communication System and evaluate digital and reproducible size of the implants and their correct position .

This is to demonstrate the superiority of modern digital tools in the preoperative preparation in Orthopaedics set.

详细描述

Modern joint replacements in orthopedic surgery allow to restore locomotion. More than 150,000 hip replacements are performed each year in France . The optimization results going restoration of the lengths of members and anatomy .

Preoperative planning of hip replacements optimizes the return of the hip rotation center . Preoperative planning of hip prothesis is practiced by layer on radiographs whose scaling is imprecise . The recent TraumaCad system ( Brainlab® ) allows adjustment of the scales for each patient and the virtual positioning of implants to simulate the response to the return of geometric parameters of the hip.

Preoperative planning by TraumaCad hip arthroplasties provides better restitution of limb length over conventional planning methods.

The standardized radiographs being the investigators want to compare this group with a control group operated without TraumaCad planning and evaluating the accuracy of the software to predict implants sizes also .

There is no risk to the patient with this procedure . The direct benefit is increased accuracy of surgical gesture to the patient and the reduction of mechanical problems related to leg length . Earnings for the orthopedic community is the postoperative evaluation. In the long term , the prosthetic technical improvement must increase the life of prostheses with therefore lower revisions and less expenditure in terms of public health.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion concerns all major patients able supported for osteoarthritis for the realization of a primary hip replacement .

排除标准

  • Minor patients
  • BMI greater than 35 patients
  • Recovery or major architectural disorder surgery ( preoperative upper inequality 2 cm or dysplastic hip)

结局指标

主要结局

postoperative inequality measured on the radiograph the 3rd postoperative day.

时间窗: day 3 after chirurgical intervention

postoperative inequality measured on the radiograph the 3rd postoperative day.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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