PATIENT-MATCHED INSTRUMENTATION Versus (vs) STANDARD INSTRUMENTATION: A RANDOMIZED CLINICAL TRIAL COMPARING POSTOPERATIVE AXIAL ALIGNMENT and COMPONENT POSITION
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Axial Alignment
研究概览
简要总结
- Title: PATIENT-MATCHED INSTRUMENTATION VS. STANDARD INSTRUMENTATION: A RANDOMIZED CLINICAL TRIAL COMPARING POSTOPERATIVE AXIAL ALIGNMENT and COMPONENT POSITION
- Short Title: Visionaire Alignment
- Methodology: Monocentric, Single Blinded, Randomized Controlled Trial
- Study Duration: November 2010 to July 2014
- Study Centres: Leicester General Hospital, United Kingdom (UK)
详细描述
Malalignment is one of the main reasons for knee arthroplasty revision. With the use of patient matched cutting block we expect better axial alignment of the components.
Research Objectives:
- The primary research objective is to evaluate the axial alignment and component position in TKA with use of Smith & Nephew's VISIONAIRE Patient Matched Technology and to compare with the alignment when standard instrumentation.
- Secondary research objectives include assessing the safety and effectiveness of the VISIONAIRE patient matched technology as compared to commonly accepted standard instrumentation in patients suffering from symptomatic osteoarthritis of the knee joint.
- Outcome Measures:
-
Implant alignment and Component position by means of CT-scans
-
Knee Society Score
-
EuroQol-5 Dimensions (EQ-5D)
-
Knee injury and Osteoarthritis Outcome Score (KOOS)
-
Oxford Knee Score
-
Knee-related adverse events
-
Standard and full leg x-ray
-
Number of Subjects: 70 (2*35)
-
Enrollment time: 18 months
-
Diagnosis and Main Inclusion Criteria: Patients with osteoarthritis of the knee requiring total knee arthroplasty
-
Study Product, Dose, Route, Regimen:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for TKA, Axial alignment between 10 degrees valgus and 20 degrees varus, BMI <36, patient must be amendable for both Genesis II total knee and Visioniare cutting blocks
排除标准
- •Insufficient femoral or tibia bone stock, inflammatory arthritis (e.g. rheumatoid arthritis), patient is immunosuppressed, has an active infection (local or systemic), patient has physical, emotional or neurological conditions that would compromise the patients compliance with rehabilitation and follow up.
研究组 & 干预措施
Visionaire
the group who will be operated by the use of Visionaire patient matched cutting blocks
干预措施: Visionaire (Procedure)
Standard Surgical technique
The group who will be operated by means fo standard surgical technique
干预措施: Standard surgical technique (Procedure)
结局指标
主要结局
Axial Alignment
时间窗: 6 weeks,
Axial alignment will be measured by means of CT scan and long leg x-ray
次要结局
- Clinical effectiveness and safety.(1 year)