Comparison of Customized Cutting Block (Visionaire™) and Conventional Total Knee Arthroplasty: A Prospective Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Mechanical Axis Alignment (Absolute Value Measured in Degrees) Using 3 Feet Long Leg Films
研究概览
简要总结
Customized cutting block and conventional cutting guide are both effective in improving accuracy and function of OA knee patients.
详细描述
Customized cutting block and conventional cutting guide are both effective in improving accuracy and function of osteoarthritic knee patients.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 60-90
- •Diagnosis of osteoarthritis or rheumatoid arthritis of the knee and qualify for surgery, as indicated by one of the following:
- •Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved;
- •Correction of varus or valgus.
- •Willing to participate and return for follow-up study visits.
排除标准
- •Vascular insufficiency
- •Previous deep vein thrombosis and pulmonary embolism
- •Previous osteotomy
- •Previous patella fracture or surgery
- •Previous healed tibia or femur fractures
- •Previous joint replacement surgery
研究组 & 干预措施
Standard knee cutting guides
Standard cutting guides use traditional instrumentation to determine knee implant positions. During surgery, a rod is placed in the leg bone and the cutting guide is attached to that rod.
干预措施: Standard knee cutting guides (Procedure)
Patient specific cutting guides
Patient specific cutting guides are custom-made for each patient based on Magnetic Resonance Imaging (MRI). Before surgery, MRI of the knee is done and used to create a cutting guide that is formed to the exact shape of the knee. The patient specific cutting guides have platforms that can be attached to the bone, so the rod does not need to be placed in the leg bone.
干预措施: Patient specific cutting guides (Procedure)
结局指标
主要结局
Mechanical Axis Alignment (Absolute Value Measured in Degrees) Using 3 Feet Long Leg Films
时间窗: 3 Months Post-operative
Femoral Valgus Angle, Tibial varus angle, Tibial slope, Femoral Flexsion/Extension angle, Implant Rotation
次要结局
- Operative time(During the procedure)
- Hemoglobin level(Post-operative day1, 2, 3)
- WOMAC score(1 year)
- Blood volume in suction drain(Post-operative Day 2)
- Intraoperative Bleeding(Intra-operative)
- WOMAC score(6 weeks)
- WOMAC score(3 Months)
- WOMAC score(6 Months)
研究者
Phonthakorn Panichkul
Phonthakorn Panichkul
Thammasat University