NCT01335438已完成4 期
Total Knee Arthroplasty Comparing Cementless to Cemented Fixation, A Prospective Comparison of Long Term Outcomes Using and Identical Design of Prosthesis
Young Hoo Kim1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 1997年1月最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Improvement in Knee Society Knee Score
研究概览
简要总结
The purpose of this study is to determine if there are any clinical or radiographic differences in cemented and cementless fixation in total knee replacement.
详细描述
Out comes measures were to determine:
- whether the knee and function scores and the radiographic results of the knees with a Nexgen cemented knee prosthesis would be better than those with an Nexgen cementless prosthesis.
- whether the patients with a Nexgen cemented knee prosthesis would have a better range of knee motion than those with an Nexgen cementless prosthesis.
- whether patient satisfaction and preference would be better in the patients having a Nexgen cemented knee prosthesis than those of patients having an Nexgen cementless knee prosthesis
- whether complication rate would be less in the knees with a Nexgen cemented knee prosthesis than in the knees with an Nexgen cementless prosthesis.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease
排除标准
- •Inflammatory disease
- •patient with other Lower extremity disease which may affect functional outcome
- •Neurologic disease effecting patients lower extremity
- •Revision surgery
- •Patient not medically cleared for bilateral surgery
结局指标
主要结局
Improvement in Knee Society Knee Score
时间窗: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery
change in knee score will be compared with initial score, until mean follow up of 25 years.
次要结局
- Improvement in the Range of Motion(Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery)
研究者
Young Hoo Kim
Professor and Director
Ewha Womans University
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Comparison of Total Knee Arthroplasties With Oxidized Zirconium and Cobalt Chromium Femoral ComponentsOsteoarthritisNCT01336595Ewha Womans University331
Unknown
不适用
Cemented vs Cementless in Bilateral TKATotal Knee ArthroplastyOsteoarthritisNCT04496102Thammasat University50
招募中
4 期
Cemented versus Uncemented Partial Knee Arthroplasty Trial – The CUPKAT Trial – A prospective, randomized controlled trialM17.9Gonarthrosis, unspecifiedDRKS00021303niversitätsklinikum Heidelberg306
招募中
不适用
Cemented vs. uncemented implantation of total knee endoprostheses using robotic surgeryM17.1Other primary gonarthrosisDRKS00023631Medizinische Hochschule Hannover128
已完成
不适用
Total Knee Arthroplasty (TKA) Cemented Versus Cementless Tibial Prosthesis StudyPost-traumatic OsteoarthritisRheumatoid ArthritisOsteoarthritisNCT01041937Washington University School of Medicine106