Total Hip Prosthesis Assisted by Computer Based on Pre-operative EOS Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Positioning of the cup in the 'security zone'. Comparison performed in immediate post-operative
研究概览
简要总结
Computer assistance in prosthetic hip surgery is able to improve the accuracy of the surgery: Associating hip navigation and EOSTM imaging pre-operatively could simplify the procedure of hip navigation in lateral decubitus while maintaining the accuracy of the technique
详细描述
Hip navigation based on preoperative EOS(TM) imaging could help to improve the accuracy of cup positioning like other computer assisted hip surgery, but it would also simplify the procedure in lateral decubitus. Indeed, the registration of the controlateral antero superior iliac spine and the pubis is not necessary with this technique. The target population of the study is the one affected with primitive hip osteoarthritis for which an indication of prosthesis of total hip has been chosen Expected Result: Simplification of the procedure of navigation of the cup. Decrease in the number of cups positioned out of the "security zone" compared to the standard manual technique of cup positioning. A result of 50% of good positioning is expected with the manual technique versus 80% with the technique of navigation based on EOS(TM).
MAIN OBJECTIVE: Compare the surgical treatment of total hip prosthesis without assistance by computer and total hip prosthesis with navigation based on imaging EOSTM pre-operative Comparative clinical trial of superiority, randomized in single blind, in 2 parallel groups: -Group 1: Installation of hip prosthesis without assistance by computer -Group 2: Installation of hip prosthesis with assistance by computer based on imaging EOS(TM)
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 (Participant)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nosologic criteria :
- •Primitive clinic hip osteoarthrosis
- •secondary secondary clinic hip osteoarthrosis : osteonecrosis of femoral head posttraumatic
- •Primitive radiological hip osteoarthrosis,
- •Indication of total hip prosthesis
- •Free informed and written consent, dated and signed by the patient and the investigator before any examination required by the research
- •Subject affiliated or beneficiary of the social security
- •Man or woman aged from 40 to 90 years
排除标准
- •The navigation based on EOSTM imaging. requires the visualization on the EOSTM. pre-operative radiography of 6 radiological bone markers. The non-viewing of these markers is a criterion for exclusion of the study.
- •anaesthetic contraindication
- •pregnant women
- •Persons under the control of justice
研究组 & 干预措施
Treatment 1
Reference group, installation of hip prothesis following standard procedure
干预措施: Prosthetic hip surgery, operated under manual control (Procedure)
Treatment 2
:treatment group,installation of hip prosthesis with assistance by computer based on imaging EOS
干预措施: Prosthetic hip surgery operated under navigation based on EOS imaging (Procedure)
结局指标
主要结局
Positioning of the cup in the 'security zone'. Comparison performed in immediate post-operative
时间窗: The measure of the positioning of the cup will be carried out on the control scanner post-operatively at 3 months
次要结局
- Average surgical Time(at inclusion)
- Post-operative dislocation(at 1 year of the occurrence of at least 1 episode of dislocation post-operatively)
- Quality of live score(at 3 month,6 month,and 12 months)
- Early sign of radiographic unsealing(comparison at one year)
- Functional Score of Harris and the score PMA(at 3 month,6 month, and 12 months)