NCT04496102Unknown不适用
Comparison of Efficacy Between Cemented and Cementless Total Knee Arthroplasty in Bilateral Total Knee Arthroplasty. A Prospective Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Compare mean Forgotten joint score between 2 groups
研究概览
简要总结
To compare the functional outcomes between cemented and cementless TKA in bilateral knee replacement patient.
详细描述
To compare early functional outcomes, radiographic finding and operative time between cemented and cementless modern implant in sequential bilateral total kee arthroplasty.
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, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA status 1 or 2
- •Diagnosed with bilateral osteoarthritis of the knees
- •Participant understand and consent to the protocol of the trial
排除标准
- •Morbid obesity (BMI >40)
- •Inflammatory arthritis
- •Osteoporosis
- •Metabolic bone disease
- •Bone defect that seen from radiographs
结局指标
主要结局
Compare mean Forgotten joint score between 2 groups
时间窗: at 1 year
The total score ranges from 0-100, where a high score is the best outcome
次要结局
- Radiological finding(post-op 2, 6 week, 3, 6, 12 month)
- Pain level(Once daily 1-14 days after surgery then once a week until 3 months)
- Operative time(intra-operative assessment)
- modified the Western Ontario and McMaster Universities Osteoarthritis Index score(post-op 2, 6 week, 3, 6, 12 month)
- complication(until 1 year after surgery)
- Range of knee motion(post-op 2, 6 week, 3, 6, 12 month)
研究者
Supakit Kanitnate
Principal Investigator
Thammasat University
研究点 (2)
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