NCT03511144撤回不适用
A Prospective Randomised Double Blind Single Centre Study Comparing Measured Resection and Ligament Balancing Implantation Techniques Using the Unity Knee™ Total Knee System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Corin
- 主要终点
- Posterior condylar offset (PCO)
研究概览
简要总结
A comparison of two Unity Knee™ tissue-balancing techniques by analysing the results from X-rays and patient questionnaires.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects suitable for the Unity Knee™ Total Knee System according to the product "Instructions for use"
- •Over 18 years old
- •Male and female subjects who are skeletally mature
- •Subjects who have a smartphone (iOS or Android) with internet connection via mobile Internet data or Wi-Fi connection
- •Subjects able to understand what is expected of them and be able to comply with the study protocol requirements
排除标准
- •Any subject listed for a revision total knee replacement or conversion of a unicondylar replacement to a total knee replacement on the operative knee
- •Any subject with fixed flexion contracture greater than 20 degrees
- •Any subject with varus/valgus deformity greater than 15 degrees
- •Any subject with confirmed osteoarthritis or other pathologies affecting the contralateral knee that is anticipated to require surgery within 12 months
- •Any subjects with contralateral knee replacement that is anticipated to require revision surgery within 12 months
- •Any subject whose prospects for a recovery to independent mobility would be compromised by known co-existent, medical problems
- •Any subject with a known sensitivity to device material
- •Any subject who is pregnant
- •Any subject currently a prisoner
- •Any subject known to be a drug or alcohol abuser, or have a psychological disorder that could affect follow-up care or treatment outcomes
- •Any subject currently involved in any personal injury litigation, medical-legal or worker's compensations claims
- •Any subject unable to read and understand English
研究组 & 干预措施
Measured resection
Active Comparator
Total knee replacement using the Unity Knee™ implanted with the measured resection surgical technique
干预措施: Unity Knee™ TKR using measured resection (Device)
Ligament balancing
Active Comparator
Total knee replacement using the Unity Knee™ implanted with the ligament balancing surgical technique
干预措施: Unity Knee™ TKR using ligament balancing (Device)
结局指标
主要结局
Posterior condylar offset (PCO)
时间窗: 6 weeks post-op
Any difference in PCO from preoperative to 6 weeks post-surgery
次要结局
- Oxford Knee Score (OKS)(Up to 24 months post-op)
- Joint line in extension(6 weeks post-op)
- Joint line in flexion(6 weeks post-op)
- Femoral flexion angle(6 weeks post-op)
- Distal femoral component angle(6 weeks post-op)
- Tibial component angle(6 weeks post-op)
- Tibial slope(6 weeks post-op)
- Hip-knee-ankle (HKA) angle(6 weeks post-op)
- Knee injury and Osteoarthritis Score - Physical Function Shortform (KOOS-PS)(Up to 24 months post-op)
- Hospital Anxiety and Depression Scale (HADS)(Up to 6 months post-op)
- EuroQoL 5-dimension health state (EQ-5D 5-level)(Up to 6 months post-op)
研究者
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