跳至主要内容
临床试验/NCT05266482
NCT05266482招募中不适用

Personal Feedback on Patient-reported Outcomes to Fulfil or Exceed Preoperative Expectations of Primary Total Knee Arthroplasty Patients: PAK-study.

Kliniek ViaSana1 个研究点 分布在 1 个国家目标入组 452 人开始时间: 2022年3月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
452
试验地点
1
主要终点
Patients' expectations

研究概览

简要总结

Despite positive results following total knee arthroplasty (TKA), some patients are dissatisfied after recovery. Unfulfilled expectations is a key predictor of dissatisfaction. The aim of this study is to investigate if more patients fulfil or exceed their preoperative expectations one year after TKA when personal feedback on their PROs is given.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

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

入选标准

  • Planned for primary TKA in Kliniek ViaSana
  • Signed informed consent

排除标准

  • Aged under 18 years
  • Do not possess an own email adress,
  • Do not have a thorough command of the Dutch language,
  • Previously received contra-lateral primary TKA and/or unicompartmental KA.

结局指标

主要结局

Patients' expectations

时间窗: 12 months after surgery

The percentage (0%-100%) of patients who fulfil or exceed their preoperatively set expectations 12 months after TKA surgery. Measured using HSS-KRES.

次要结局

  • Patients' satisfaction(3, 6 and 12 months after surgery)
  • Pain relief(3, 6 and 12 months after surgery)
  • Functional improvement(3, 6 and 12 months after surgery)
  • Patients' expectations(3 and 6 months after surgery)
  • Perceived recovery(3, 6 and 12 months after surgery)

研究者

发起方
Kliniek ViaSana
申办方类型
Other
责任方
Sponsor

研究点 (1)

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