NCT00755144已完成不适用
A Prospective Randomized Study on Early Clinical and Functional Outcome of the ROCC and LCS Total Knee Arthroplasty Implant Designs
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- American Knee Society Score
研究概览
简要总结
This is a prospective Randomised Control Trial to compare the Early Clinical and Functional Outcome of the ROCC and LCS total knee arthroplasty implant designs.
详细描述
This study compares two similar designs of cementless rotating bearing total condylar knee replacements. The study will be conducted at a single clinical unit with a senior orthopaedic surgeon implanting all devices.Their performances will be assessed by clinical scores and comprehensive function outcome documentation undertaken by qualified physiotherapists. The persons undertaking the assessments will be blinded to which implants the patients have.
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
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suitable for cementless knee replacement
- •Patients skeletally mature and under 80 years of age at pre-operative clinic
- •Patients presenting with osteoarthritis of the knee
- •Patients must be ambulatory at time of pre-operative clinic
- •Patients must be able to understand instructions and be will to return for follow-up
排除标准
- •Previous knee surgery (except arthroscopic/open menisectomy)
- •Patients with inflammatory arthritis
- •Patients with significant medical co-morbidity - ASA IV
- •Disorders causing abnormal gait or significant pain
- •Patients unable to consent
- •Severe visual impairment
研究组 & 干预措施
1
Experimental
ROCC
干预措施: ROCC Knee (Device)
2
Active Comparator
LCS
干预措施: LCS Knee (Device)
结局指标
主要结局
American Knee Society Score
时间窗: Preoperative, 8weeks, 1 year
次要结局
- WOMAC(preoperative, 8 weeks, 1 year)
- VAS Pain(Preoperative, 4weeks, 8weeks, 3months, 1 year)
研究者
研究点 (1)
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