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临床试验/NCT04637490
NCT04637490已完成不适用

Patellar Resurfacing in Total Knee Arthroplasty Leads to Better Isokinetic Performance and Higher Clinical Scores

Gulhane Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
isokinetic test

研究概览

简要总结

For decades there have been concerns about patellar resurfacing (PR) in total knee arthroplasty (TKA) and the individual preference of the surgeon is still the main determinant of whether or not resurfacing is applied. According to preference, surgeons can be categorized in 3 main groups of those who usually, selectively or rarely resurface. The aim of this prospective, randomized, controlled study to is compare the isokinetic performance and clinical outcome of TKAs with PR and without PR.

详细描述

Patients undergoing TKA for primary osteoarthritis of the knee are randomly assigned to either the PR or non-PR groups. The differences between groups with respect to age, BMI, gender, and preoperative Knee Society Score (KSS), and isokinetic performance are evaluated. Patients are evaluated at postoperative 3, 6, and 12 months with KSS and at 6 months and 1 year with isokinetic measurements.

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, Investigator)

入排标准

年龄范围
55 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 55 to 80 years
  • unilateral primary osteoarthritis

排除标准

  • bilateral osteoarthritis
  • inflammatory arthritis
  • post-traumatic osteoarthritis
  • previous knee surgery
  • neuromuscular diseases

结局指标

主要结局

isokinetic test

时间窗: Change from preoperative isokinetic test results at 6th months and 12th months isokinetic test results

isokinetic test during extension and flexion of the knee

次要结局

  • Knee Society Score (KSS): It has two different subscales: Knee and Function 100-80: Excellent 79-70:Good 69-60:Fair below 60:Poor(Change from preoperative KSS results at 3rd months, 6th months and 12th months KSS results)

研究者

发起方
Gulhane Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Deniz CANKAYA

Associate Professor

Gulhane Training and Research Hospital

研究点 (2)

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