A Prospective Randomized Controlled Trial Evaluating Patient Specific Total Knee Arthroplasty Using Kinematic Alignment Versus Ligament-balanced, Mechanical Alignment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change of Pain after kinematic vs mechanical aligned TKA
研究概览
简要总结
A promising new approach in total knee arthroplasty (TKA) for severe osteoarthritis of the knee joint is the the kinematic aligned procedure (KA). This technique provides prosthesis-positioning based on natural and individual axes of movement.
Although first series have shown satisfying results, further verification by prospective studies and final meta-analyses will be required.
Thus, the kinematic alignment represents one of the few new developments in TKA.
Provided that patients are willing to participate in the study, patients data are collected preoperatively and during routine follow-up examinations and evaluated prospectively. Patients will receive either a conventionally mechanical aligned arthroplasty or a kinematical aligned TKA, according to a randomized procedure.
The kinematic alignment will be achieved by the use of custom-made cutting-blocks. Therefore, the patients will undergo a computed tomography of the whole leg on the affected side. This is mandatory in order to provide the individually produced cutting blocks.
In order to ensure comparability, patients are stratified regarding their age and gender before inclusion.
Outcome will be measured by the use of standard scoring systems regarding function, pain and ROM (range of motion) three, six and 12 months after surgery.
This study is a monocentric, prospective, randomized and controlled open study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Severe osteoarthritis of the knee joint, intended for total knee arthroplasty
排除标准
- •malalignment with varus of more than 5° or valgus malpositioning, joint instability
结局指标
主要结局
Change of Pain after kinematic vs mechanical aligned TKA
时间窗: 3; 6; 12 months
The pain will be measured with the Visual Analog Scale (VAS), ranging from 1 to 10. 1 is meaning no pain, 10 is meaning the worst pain imaginable.
Change of Function after kinematic vs mechanical aligned TKA (KSS)
时间窗: 3; 6; 12 months
Function of the artificial joint will be assessed by the use of the Combined Knee Society Score (KSS). The KSS has a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
Change of Function after kinematic vs mechanical aligned TKA (WOMAC)
时间窗: 3; 6; 12 months
Function of the artificial joint will be assessed by the use of the Western Ontario and McMaster Universities Arthritis Index Score (WOMAC). The WOMAC survey is comprised of 24 items divided into three subscales: Pain (5 items), stiffness (2 items), and physical function (17 items). Patients are asked a range of questions about their ability to carry out daily activities such as using the stairs, rising from sitting, lying in bed and conducting light or heavy domestic duties. All the items are scored on a scale of 0-4 (lower scores indicate lower levels of symptoms or physical disability). Values are summed up for a combined WOMAC score.
Change of Range of Motion (ROM) after kinematic vs mechanical aligned TKA
时间窗: 3; 6; 12 months
To assess range of motion a Standard Goniometer will be used. Measurements will be obtained after 3, 6, 12 months
Change of Function after kinematic vs mechanical aligned TKA (OKS)
时间窗: 3; 6; 12 months
Function of the artificial joint will be assessed by the use of the Oxford Knee Score (OKS). The OKS is a patient reported outcome measure that consists of 12 questions about an individual's activities of daily living and how they have been affected by pain after total knee arthroplasty. All questions are scored from 0-4 where four is the best outcome and total scores range from 0 (worst outcome) to 48 (best outcome).
次要结局
未报告次要终点