Gait Analysis, Stair Performance and CT-based Micromotion Analysis in Robotic Assisted Total Knee Arthroplasty Comparing Bi-cruciate Retaining vs Cruciate Retaining Implants: A Single Centre Patient-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- CT-RSA measured maximum total point of motion(MTPM)
研究概览
简要总结
The goal of this clinical trial is to compare the function of the knee after retaining or sacrificing the anterior cruciate ligament in robotic assisted knee arthroplasty.
The main questions it aims to answer are:
Does retaining the anterior cruciate ligament improve postoperative gait? Participants will perform
- Gait analysis
- Stair performance test
- CT based Micromotion analysis of the implant micromovement
详细描述
A randomized controlled clinical trial intended to compare walking function and movement of the prosthesis after robot-assisted knee replacement surgery with two knee replacement designs; One prosthesis is preserving the anterior cruciate ligament (Smith+Nephew Journey II XR) and the other is sacrificing the anterior cruciate ligament (Smith+Nephew Jourrney II CR).
It is common to remove anterior cruciate ligament during knee replacement surgery. There is speculation about this weakens the balance in the operated knee and whether this can explain some of the problems that up to 20% experience after knee replacement surgery.
Preservation of the anterior cruciate ligament during knee replacement surgery may provide a more natural movement and better balance in the operated knee, and this in turn could provide increased patient satisfaction.
Previous studies have shown that knee replacement surgery where the anterior cruciate ligament is preserved has an increased incidence of per- and postoperative complications and reduced implant survival. Robot assisted navigation in knee arthroplasty surgery has shown the possibility of increased precision and accuracy when implanting the knee prostheses, and therefore might provide increased satisfaction when performing elective knee prosthetic surgery with robotic assistance and at the same time preserving the anterior cruciate ligament without an increased risk of complications.
In this study, postoperative function is assessed by looking at whether the walking pattern has normalized.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Severe osteoarthritis Ahlbäck grade 3 or 4 affecting 2-3 compartments
- •Ability to preoperatively walk 30 m independently without support before surgery
- •Ability to give written consent.
- •CPAK (Coronal Plane alignment of the Knee) I, II or III
排除标准
- •Previous cruciate ligament surgery in affected knee
- •Previous osteotomy in affected knee,
- •Posttraumatic arthritis in affected knee
- •History of infectious arthritis
- •Rheumatoid arthritis
- •Significant preoperative varus or valgus deformity >15º
- •Evidence of damaged Anterior Cruciate Ligament and/or Posterior Cruciate Ligament
- •Flexion contracture > 10 º, - Planning reveals the need for a complex implant ( stem, augment or higher level of constraint).
结局指标
主要结局
CT-RSA measured maximum total point of motion(MTPM)
时间窗: 6,12 and 24 months after surgery
CT-RSA measured maximum total point og motion(MTPM)in millimeters and rotation of the implant in degrees compared to baseline value
Preferred walking speed (meter/minute) after surgery
时间窗: twelve months after surgery.
Evaluation of gait with preferred walking speed (meter/minute) measured on a electronic walkway system
次要结局
- step length in mid stance phase (cm)(twelve months after surgery.)
- stride length(cm)(twelve months after surgery.)
- double-leg support time(s)(twelve months after surgery.)
- evaluation of max walking speed(m/minute)(twelve months after surgery.)
- single leg support time(s)(twelve months after surgery.)
- stair performance(s)(twelve months after surgery.)
- KOOS-PS (Knee Injury and Osteoarthritis Outcome score)(twelve months after surgery.)
- Clinical evaluation of range of motion .(twelve months after surgery.)
- Rating outcome using EQ-5D-5L(European quality of life index version 5D-5L),(twelve months after surgery.)
- IKSS (International Knee Society System knee and function score)(twelve months after surgery.)
- FJS-12 (Forgotten Joint score)(twelve months after surgery.)
- Clinical evaluation of Mediolateral stability.(twelve months after surgery.)
- Rating pain using NRS (Numeric Rating Scale).(twelve months after surgery.)
- Clinical evaluation of Anteroposterior stability.(twelve months after surgery.)