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临床试验/NCT05349461
NCT05349461Unknown不适用

Comparison of Post-operative Knee Range of Motion and Functions Between Intraoperative Complete and Incomplete Patellofemoral Articular Contacts in Patients Undergoing 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 60 人开始时间: 2021年4月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Knee range of motion (ROM)

研究概览

简要总结

The purpose of this study is to compare clinical outcome in knee range of motion and functions between intraoperative complete and incomplete patellofemoral articular contacts

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
  • •Age 50-80 year

排除标准

  • •Revision surgery
  • •Bilateral total knee arthroplasty
  • •History of patellar fracture
  • •History of patellar chondromalacia
  • •History of Patellar instability

研究组 & 干预措施

Complete contact

Active Comparator

干预措施: Complete patellofemoral articular contact (Procedure)

Incomplete contact

Active Comparator

干预措施: Incomplete patellofemoral articular contact (Procedure)

结局指标

主要结局

Knee range of motion (ROM)

时间窗: Change from baseline Knee range of motion (ROM) at 3 months, 6 months, and 12 months after surgery

Goniometer measure range of motion (minimum 0, maximum 145)

Knee flexion

时间窗: Change from baseline knee flexion at 3 months, 6 months, and 12 months after surgery

Goniometer measure knee flexion (minimum 135, maximum 145)

Knee extension

时间窗: Change from baseline knee extension at 3 months, 6 months, and 12 months after surgery

Goniometer measure knee extension (minimum -10, maximum 0)

次要结局

  • Prevalence of anterior knee pain ,AKP(Change from baseline Prevalence of anterior knee pain ,AKP 3 months, 6 months, and 12 months after surgery)
  • Knee Society and Knee Society function score(Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery)
  • Oxford knee score(Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery)
  • New patellar score(Change from baseline new patellar score at 3 months, 6 months, and 12 months after surgery)

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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