A Randomized Trial Comparing Navigated and Conventional Implantation Techniques in Knee Replacement Surgery. Influence on Operative Result, Health-Related Quality of Life, and Coordinative Abilities.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 477
- 试验地点
- 16
- 主要终点
- Physical functioning as measured with the Western Ontario and McMasters osteoarthritis index
研究概览
简要总结
This study is undertaken to investigate the effect of navigated knee implantation surgery on physical function, joint stiffness, pain, quality of life and coordinative abilities.
One group of patients will receive navigated knee implantation surgery, the other traditional knee implantation surgery, without use of the navigation system.
The study is designed as a randomized trial. That means that all patients who have given their consent to participate in this study will be allocated to either navigated or conventional surgery by chance.
A total of 477 patients will be included in this study and will be followed up for 12 month.
In this period all patients will be asked to fill in functional and quality of life questionnaires at baseline, 6 weeks and 3, 6 and 12 month follow-up. Coordinative abilities will be evaluated once in the time-frame 3 to 6 months postoperatively.
详细描述
Various risk factors influencing the success of Total Knee Arthroplasty (TKA) have been studied.
Today age, gender, primary or revision surgery, comorbidities and baseline characteristics are known to influence the health-related quality of life after TKA.
It is thought, that accurate mechanical alignment and ligament balance ensure optimal kinematic performance and wear, which in turn improves long-term outcome.
During preparation of the bone for the implantation of the knee prosthesis, numerous cuts are performed. Traditionally mechanical adjusted jigs are used to accurately align and position the instruments.
Since this alignment process is a source for deviation even in experienced surgeons, several navigation systems were developed. Using these systems, the surgeon is guided in the location of the instruments with the help of a computer.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who are scheduled to receive a Total Knee Arthroplasty at the participating institutions for primary diagnosis of osteoarthritis are candidates for inclusion in the study.
排除标准
- •A history of septic arthritis in the joint to operate
- •Amputations
- •Neurological deficits
- •Inability to complete the questionnaires because of cognitive or language difficulties
- •Prior knee arthroplasty in the joint to operate
- •Prior arthroplasty in another weight-bearing joint within the last 6 months
结局指标
主要结局
Physical functioning as measured with the Western Ontario and McMasters osteoarthritis index
次要结局
- Leg-specific pain and stiffness as measured with the WOMAC
- The Lequesne Knee Score
- The physical component summary of the SF-36
- EuroQoL-5D
- Patient satisfaction
- Balance abilities as investigated with the Biodex Stability System®
- Motoric coordination as assessed by a shortened version of the "Dortmunder modified Romberg Test for Seniors"
- Proprioception assessed according to guidelines established by Barrack and Swanik
- Axis relations evaluated by postoperative standardized lateral and AP X-rays