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临床试验/NCT03650426
NCT03650426已完成不适用

Comparison Between the Onlay and Inlay Techniques for Patellar Resurfacing in Posterior Cruciate Ligament-Substituting Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial

Navamindradhiraj University1 个研究点 分布在 1 个国家目标入组 235 人开始时间: 2018年2月20日最近更新:
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
235
试验地点
1
主要终点
New patellar score

研究概览

简要总结

The purpose of this study is to compare clinical outcome in posterior cruciate ligament-substituting total knee arthroplasty with onlay patellar resurfacing technique and inlay patellar resurfacing technique

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

性别
All
接受健康志愿者
否

入选标准

  • •Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty

排除标准

  • •Valgus deformity
  • •History of inflammatory arthroplathy
  • •Previous fracture or open surgery on the same knee
  • •History of patellar instability

研究组 & 干预措施

Onlay patellar resurfacing technique

Active Comparator

干预措施: Total knee with onlay patellar resurfacing technique (Procedure)

Inlay patellar resurfacing technique

Experimental

干预措施: Total knee with inlay patellar resurfacing technique (Procedure)

结局指标

主要结局

New patellar score

时间窗: Change from baseline new patellar score at 3 months, 6 months, and 12 months after surgery

New patellar score (minimum 0, maximum 30)

Prevalence of patellar crepitus complication

时间窗: Change from baseline patellar crepitus complication 3 months, 6 months, and 12 months after surgery

Prevalence of patellar crepitus complication (present, absent)

range of motion of knee

时间窗: Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery

Knee Society and Knee Society function score (minimum 0, maximum 200)

Knee Society and Knee Society function score

时间窗: Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery

Knee Society and Knee Society function score (minimum 0, maximum 200)

Change of post-operative anterior knee pain

时间窗: Change from baseline Visual Analog Scale for anterior knee pain at 3 months, 6 months, and 12 months after surgery

Visual Analog Scale for anterior knee pain (minimum 0, maximum 10) Do higher values represent a worse outcome

Oxford knee score

时间窗: Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery

Oxford knee score (minimum 0, maximum 48)

Prevalence of anterior knee pain ,AKP

时间窗: Change from baseline Prevalence of anterior knee pain ,AKP 3 months, 6 months, and 12 months after surgery

Prevalence of anterior knee pain ,AKP (minimum 0, maximum 10)

次要结局

未报告次要终点

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 (1)

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