Clinical Evaluation of the Low Contact Stress (LCS) Classic and Universal Mobile-bearing Total Knee System. The Asian LCS User Group - 'The Dragon Knee Study'
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 607
- 试验地点
- 1
- 主要终点
- Change in Oxford Knee Score
研究概览
简要总结
To determine how the LCS mobile bearing knee system works within the Asian Population.
详细描述
The objective of this clinical evaluation is to compile a profile of the performance of the LCS Mobile bearing total knee system in normal clinical practice within the Asian Population. Performance will be assessed using specific surgeon and patient based outcome scores.
Total subject enrolled 505; 6 subjects did not receive device. Total subjects received device 499.
Among those who received devices, 391 subjects unilateral and 108 bilateral, therefore, total 607 knees in the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Administrative - the patient is able to understand the evaluation, is able to give consent and will comply with the postoperative follow up regime.
- •Diagnosis - idiopathic osteoarthritis, rheumatoid arthritis, post traumatic arthritis or any other pathology that in the opinion of the clinical investigator requires a primary total knee arthroplasty.
- •Implant suitability - patients who in the opinion of the Clinical Investigator are considered suitable for treatment with a mobile bearing knee system (the LCS Classic or Universal).
- •Bilateral patients - simultaneous bilateral patients are included. Staged bilateral patients are included if the second procedure is performed within the one-year recruitment period. Staged bilateral patients where the second procedure is performed outside of the one-year recruitment period will only be included if the second procedure is performed within 6 months of the end of the one-year recruitment period.
- •Age - the upper age limit is set at 75 years and expected to live through the 5 years study period.vi. Ethnic Origin - patients must be Asian in ethnic origin
- •Unicondylar / High Tibial Osteotomy (HTO) conversion - patients that are being converted from a unicondylar / HTO procedure are included providing the reason for conversion is due to progression of the disease process affecting the other condyle. Patients that are converted and have evidence of infection / aseptic loosening / loss of bone stock are excluded.
排除标准
- •Patients with a known history of poor compliance to medical treatment.
- •Patients that require revision surgery
- •Patients with gross ligamentous insufficiency.
- •Patients with a severe valgus deformity (15 degrees or greater)
- •Patients with a severe varus deformity (20 degrees or greater)
- •Patients with a fixed flexion contracture (30 degrees or greater)
- •Patients over the age of 75 years.
结局指标
主要结局
Change in Oxford Knee Score
时间窗: 5 years
Oxford Knee Score will be summarized pre-operatively and at each subsequent post-operative follow-up. The change from pre-op to final post-operative assessment at 5 years will be derived and used as the analysis variable.
次要结局
- Change in Quality of Life Score (SF-36), Knee Society Score, Anterior Pain and radiographic/radiolucent details from pre-op to 5 year post-op follow up.(5 years)
- Adverse Events(5 years)