跳至主要内容
临床试验/NCT02536573
NCT02536573已完成不适用

Prospective, Randomized Study to Evaluate Total Hip Arthroplasty With and Without Radlink Surgical Positioning Software

Anderson Orthopaedic Research Institute0 个研究点目标入组 200 人开始时间: 2015年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
主要终点
Radiographic cup abduction angle

研究概览

简要总结

This is a prospective, randomized study of total hip arthroplasty with and without the use of Radlink surgical positioning software. The investigators are interested in discovering whether the use of the Radlink software will provide more accurate acetabular cup position when compared with surgeon estimates based on visual inspection of fluoroscopic images.

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

  • Total hip arthroplasty

排除标准

  • 未提供

研究组 & 干预措施

Control

No Intervention

Intraoperative fluoroscopy of the hip is used to visually estimate the acetabular cup angle and make any necessary adjustments.

Radlink Surgical Positioning System

Experimental

Fluoroscopic image of the hip joint is imported into the Radlink Surgical Positioning software. The software calculates a target cup position using bony landmarks, and the surgeon matches the cup to the target.

干预措施: Radlink Surgical Positioning Software (Other)

结局指标

主要结局

Radiographic cup abduction angle

时间窗: 4 month postoperative

Angle of acetabular component in coronal plane measured on x-ray

Radiographic cup anteversion angle

时间窗: 4 month postoperative

Angle of acetabular component in sagittal plane measured on x-ray

次要结局

  • Variance of cup angles measured on x-ray(4 month postoperative)

研究者

申办方类型
Other
责任方
Sponsor

相似试验