跳至主要内容
临床试验/NCT06891807
NCT06891807招募中不适用

RobAR Study: Comparison of Image Based Robotic TKA Vs Imageless Augmented Reality-Assisted TKA

Medisch Centrum Latem1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年7月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
250
试验地点
1
主要终点
radiographic alignment and positioning of the implant on full-leg standing X-Rays

研究概览

简要总结

This study compares the accuracy of two different techniques in placing a total knee replacement. In one technique, accurate instrument placement is facilitated by a robot, and in the other technique, augmented reality is used for correct instrument placement. Both surgical techniques are already commonly used. During both the robotic technique and the augmented reality technique, the additional information (angles - axes) obtained during the operation is used to optimize the placement of the various prosthesis components.

Patients that were recently diagnosed with advanced osteoarthritis of the knee can participate in this study. This means that the cartilage of the knee is affected by wear and tear. This causes pain, stiffness and swelling resulting in reduced mobility. When non-operative treatments are insufficient in treating the osteoarthritis, surgery is proposed wherein a knee arthroplasty is performed.

The goal of this study is to further optimize and personalize patient care. Additionally, the aim of the study is to investigate whether both techniques are equivalent in optimally placing the prosthesis and whether both techniques lead to comparable results.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Subjects from 18 years up to 85 years old
  • •Patients eligible and planned for a primary Total Knee Arthroplasty
  • •Patients willing to sign the informed consent form (ICF) for participating in this study
  • •Indication of surgery is primary osteoarthritis

排除标准

  • •Revision knee surgery
  • •Other medical conditions contributing to the rehabilitation process of the TKA according to the surgeon, such as Parkinson's Disease, dementia, multiple sclerosis and cerebral vascular accident
  • •The patient received a TKA within the last three months or has a TKA planned in the next three months, for the contralateral knee
  • •Patient is participating in another clinical trial
  • •Patient is not able to understand Dutch, French or English
  • •Patients who did not meet all of the inclusion criteria

研究组 & 干预措施

Skywalker

Active Comparator

SkywalkerTM Robotics Assisted TKA using Evolution Medial Pivot Knee

干预措施: Robotics Assisted TKA (Device)

Pixee Knee+

Active Comparator

PIXEE Knee+ TKA using Evolution Medial Pivot Knee

干预措施: Augmented Reality assisted TKA (Device)

结局指标

主要结局

radiographic alignment and positioning of the implant on full-leg standing X-Rays

时间窗: 1 year follow-up

To evaluate the radiographic alignment and positioning of the implant on full-leg standing X-Rays at a minimum of 1 year follow up between two TKA assistive technologies. These results will be compared with the intraoperative settings for alignment and positioning of the implant.

次要结局

  • Safety and clinical outcomes of assistive TKA technologies(2 year follow-up)
  • Activity parameters(2 year follow-up)

研究者

发起方
Medisch Centrum Latem
申办方类型
Other
责任方
Principal Investigator
主要研究者

Philippe Van Overschelde

Dr. Philippe Van Overschelde, MD, Orthopaedic Surgeon

Medisch Centrum Latem

研究点 (1)

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