跳至主要内容
临床试验/NCT02997579
NCT02997579已完成不适用

Prospective Randomized Controlled Trial: Comparison of Vibration Arthrometry Between Patella Resurfacing and Patella Non-resurfacing in Total Knee Replacement Patients

Navamindradhiraj University2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2016年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
2
主要终点
change of patellar crepitus

研究概览

简要总结

Patellar crepitus is a complication of total knee arthroplasty (TKA).The development of patellar crepitus after TKA are related to many factors such as femoral component design, surgical errors, and postoperative patellar baja. However, it is unclear whether patella resurfacing or patella non-resurfacing are associate with patellar crepitus. The primary objective of this study are to compare the prevalence of patellar crepitus and the mean value of vibroacoustic signal between patellar-resurfacing and patellar non-resurfacing in TKA. The secondary objective is to study the association between patellar crepitus and vibroacoustic signal.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • primary osteoarthritis of knee

排除标准

  • rheumatoid arthritis
  • morbid obesity
  • severe patellofemoral joint destruction
  • patella maltracking
  • patellofemoral incongruent
  • inflammatory arthritis
  • refuse to participation

结局指标

主要结局

change of patellar crepitus

时间窗: pre-op, 3, 6 month

patellar crepitus investigate by physical examination

change of mean of vibroacoustic signal

时间窗: pre-op, 3, 6 month

次要结局

  • Number of patellar crepitus related to mean of vibroacoustic signal(pre-op, 3, 6 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Satit Thiengwittayaporn

Associate Professor

Navamindradhiraj University

研究点 (2)

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