Randomised Control Trial of Patient Specific Instrumentation vs Standard Instrumentation of the GMK-Sphere (Global Medacta Knee) Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Change from Baseline Gait Kinematics at 1-Year
研究概览
简要总结
Total knee replacements are operations that are offered to patients who have severe arthritis pain that is affecting daily activities that is no longer controlled with painkillers. The operation will replace the worn joints with metal implants and a plastic spacer. Total knee replacements are successful operations in the vast majority of patients. However, a small minority of patients are not entirely satisfied with the outcome of their knee replacement. Researchers are studying whether the precise positioning of the implant has an effect on the outcome.
This study will look at whether patient-specific instrumentation improves implant position and if it leads to improved patient function so that we know what to recommend in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
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
- •Patients with osteoarthritis of the knee which is sufficiently symptomatic to require knee arthroplasty as assessed by their consultant orthopaedic surgeon
排除标准
- •Patients with inflammatory arthropathy, patients requiring bone augmentation, patients with ligament incompetence or valgus deformity >5 degrees.
结局指标
主要结局
Change from Baseline Gait Kinematics at 1-Year
时间窗: 1 year post-operatively
Gait of patients will be analysed pre-operatively, six-weeks post-operatively, and 1-year post-operatively by 3D motion capture technology. The change measured over time at 1-year will be the primary outcome.
次要结局
- Patient Satisfaction (Pain/Hospital experience/functional ability/Surgery expectations)(1 year post-operatively)
- EuroQol-5 Dimensions (EQ-5D) (Patient reported outcome measure of patients' perception of their overall health)(6 weeks post-operatively)
- Knee range of motion(1 year post-operatively)
- EuroQol-5 Dimensions (EQ-5D) (Patient reported outcome measure of patients'(1 year post-operatively)
- Oxford Knee Score (Patient reported outcome measure of pain and function)(1 year post-operatively)
- Short Form-12 (SF-12) (Patient reported outcome measure of general quality of life)(1 year post-operatively)