Unity Total Knee Replacement: Prospective Single-centre Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Corin
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- Power of knee extension
研究概览
简要总结
This study will compare two different surgical methods used in total knee replacement with the Unity Total Knee Replacement System. The study will evaluate these two methods based on patients' ability to perform various tasks prior to surgery and at 4 time points during the first 12 months after surgery.
详细描述
This study will be conducted at a single centre. The study has two treatment groups. One group of 50 knees (approximately 50 subjects) will have a surgical method that uses mechanical alignment (alignment based on how the leg and knee joint move) to determine the proper position of the knee replacement device. The other group of 50 knees (approximately 50 subjects) will have a surgical method that uses anatomical alignment (alignment based on how the anatomy/structure of the leg and knee joint) determine the proper position of the knee replacement device. Subjects will be randomly assigned to one of the two groups. Clinical and functional tests will be conducted pre-operatively and at 6 weeks, 3 months, 6 months and 12 months to determine overall knee function. In addition, a CT scan will be completed pre-operatively and at 6 weeks to assess changes in alignment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must be listed for a primary total knee replacement using the Corin Unity Total Knee Replacement System, according to the product 'Instructions For Use'
- •The patient must give signed informed consent to participate in the study
- •The patient must be able to understand all that is expected of them and be able to comply with the study protocol
- •Male and female patients who are skeletally mature
排除标准
- •Any patient with a total knee replacement not implanted with a Corin Unity Total Knee Replacement
- •Any patient with a revision total knee replacement or conversion of a Unicondylar replacement to a total knee replacement on the operative knee
- •Any patient with fixed flexion contracture greater than 20 degrees
- •Any patient with varus/valgus deformity greater than 15 degrees
- •Any case not described in the inclusion criteria
- •Any patient who cannot or will not provide signed informed consent for participation in the study
- •Any patient whose prospects for a recovery to independent mobility would be compromised by known co-existent, medical problems
- •Any patient with a known sensitivity to device material
- •Any patient who is pregnant
- •Any patient currently a prisoner
- •Any patient known to be a drug or alcohol abuser, or have a psychological disorder that could affect follow-up care or treatment outcomes
- •Any patient currently involved in any personal injury litigation, medical-legal or worker's compensations claims
- •Any patient unable to read and understand English
结局指标
主要结局
Power of knee extension
时间窗: 12 months post-operative
Power of knee extension via peak torque of quads measured on a digital myometer.
次要结局
- Timed stairs test(12 months post-operative)
- Wii Fit balance test(12 months post-operative)
- Patient Satisfaction Score(12 months Post-operative)
- Timed up and go test(12 months post-operative)
- Single leg stance (SLS) test(12 months post-operative)
- 6 minute walk test(12 months post-operative)
- Ability to kneel(12 months post-operative)
- Sloped treadmill test(12 months post-operative)
- Walking on uneven ground(12 months post-operative)
- CT evaluation(6 weeks post-operative)
- Power of knee flexion(12 months post-operative)
- Oxford Knee Score (OKS)(12 months Post-operative)
- EuroQoL 5-dimension Health State (EQ-5D)(12 months Post-operative)
- Knee Injury and Osteoarthritis Score (KOOS)(12 months Post-operative)