Study on the Signature Personalised Patient Care System With the Vanguard Knee System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 325
- 试验地点
- 14
- 主要终点
- Mechanical Axial Alignment
研究概览
简要总结
The purpose of this study is to determine whether the percentage cases which have ideal mechanical axial alignment using the Vanguard total Knee implant with the Signature cutting blocks is higher than those without the use of Signature when measured immediately post-operatively.
详细描述
The purpose of this study is to determine whether the percentage cases which have ideal mechanical axial alignment using the Vanguard total Knee implant with the Signature cutting blocks is higher than those without the use of Signature when measured immediately post-operatively. Other outcomes will include knee assessments 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
- 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
- •painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more of the knee compartments are involved
- •correction of varus, valgus or posttraumatic deformity
- •correction or revision of unsuccessful osteotomy (wedge cut from bone to improve alignment), or arthrodesis (fusion)
- •need to obtain pain relief and improve function
- •ability and willingness to follow instructions, including control of weight and activity level.
- •a good nutritional state
- •must have reached full skeletal maturity
- •able and willing to undergo an MRI scan
排除标准
- •infection
- •osteomyelitis
- •failure of a previous joint replacement
研究组 & 干预措施
Signature Knee Guide
Vanguard Knee System with Signature Knee Guide
干预措施: Vanguard Knee System with Signature Knee Guide (Procedure)
Conventional Approach
Vanguard Complete Knee System with Conventional Approach
干预措施: Vanguard Knee System with conventional Instruments (Procedure)
结局指标
主要结局
Mechanical Axial Alignment
时间窗: Prior to Discharge: 0-2 weeks
Femoral and tibial component alignment, femoral and tibial rotational alignment, tibial posterior slope
次要结局
- Clinical Outcome(6 months, 1 year)