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对于严重髋关节或膝关节骨关节炎患者来说什么最重要？ (PATI-Project)

2026年9月23日 更新者：Vejle Hospital

对于严重髋关节或膝关节骨关节炎患者来说什么最重要？决策质量、患者参与和健康结果

This clinical trial aims to investigate if shared decision-making, and the use of an in-consultation patient decision aid (PtDA), increases the decisional quality and therefore treatment satisfaction and outcome of patients with severe hip or knee osteoarthritis.

Finally, an evaluation will be conducted on patient-reported outcomes on pain, physical function, quality of life (QoL), and patient satisfaction, up to one year after surgery.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Osteoarthritis (OA) is the most common joint disease and a major cause of disability worldwide. The condition typically affects the hip or knee, and as the condition progresses it frequently causes debilitating pain and stiffness in the affected joints; thus impairing mobility, and decreasing function and quality of life(QoL).

Approximately 10,300 primary hip arthroplasties (THA) and 10,000 primary knee arthroplasties (TKA/UKA) were performed in Denmark in 2021.

For the majority of patients with severe osteoarthritis, evidence shows that joint replacement surgery is life-changing. Despite this documented effect, not all patients achieve optimal results. Patient dissatisfaction following THA and TKA has been reported as 7 % and 11-18%, respectively.

It is hypothesized that a lack of adequate information and patient involvement in the decision process might lead to the misalignment of patients' expectations and subsequent dissatisfaction. Considerable evidence shows that patients prefer more information and greater involvement. This strongly supports the concept that patients need to be actively involved in treatment decisions.

Accordingly, increasing patient involvement in healthcare decisions may be beneficial. Shared decision-making (SDM) supports patients' active involvement in the process and improves the quality of decisions. SDM can be facilitated using a PtDA, which has shown significant benefits in a range of patient groups. However, research on SDM and PtDAs in patients with severe hip or knee OA is lacking.

The overall aim of this project is to investigate if an in-consultation PtDA increases the decision quality for patients with severe OA of the hip or knee.

研究类型

介入性

注册 (实际的)

615

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 丹麦
      • Odense、丹麦、5000
        • Odense University Hospital, OUH
      • Svendborg、丹麦、5700
        • Odense University Hospital, OUH
      • Vejle、丹麦、7100
        • Lillebaelt Hospital - Vejle

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Severe primary osteoarthritis eligible for primary total hip arthroplasty (THA) / primary total knee arthroplasty (TKA) / primary partial knee arthroplasty (UKA)
  • Able to understand and read Danish
  • Informed consent

Exclusion Criteria:

  • Previous THA, TKA, or UKA on the contralateral side
  • Cognitive impairment
  • Non-OA-related reason for the visit
  • No digital mailbox (E-boks)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Shared decision-making (SDM)

Patients will be informed by a nurse before being consulted by the surgeon randomized to SDM and use the in-consultation PtDA during the consultation on patients with severe hip or knee osteoarthritis
行为的：Shared decision-making supported by an in-consultation PtDA to patients with severe osteoarthritis in their hip or knee

The intervention group has been involved in the development process of the PtDA. After receiving a training course in SDM and the use of a PtDA, the surgeons will practice SDM supported by an in-consultation PtDA during the consultations with the participant.
无干预：Usual practice

Patients will be informed by a nurse before being consulted by the surgeon randomized to usual practice during the consultation on patients with severe hip or knee osteoarthritis

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
The participant's decisional quality according to The Hip/Knee Osteoarthritis Decision Quality Instrument (HK-DQI).
大体时间：Within one week after inclusion in the consultation

Informed Patient-Centered (IPC) decision is calculated as the percentage of patients who are well-informed and received their preferred treatment.
Within one week after inclusion in the consultation

次要结果测量

结果测量
措施说明
大体时间
Participant's engagement in the decision-making process as measured by the CollaboRATE questionnaire
大体时间：Within one week after inclusion in the consultation

Minimum value: 0. Maximum value: 100. The higher the value the more shared decision-making
Within one week after inclusion in the consultation
Participant's involvement in the decision-making process as measured by the HK-DQI questionnaire
大体时间：Within one week after inclusion in the consultation

HK-DQI, section 3, decision-making process: Minimum value: 0. Maximum value: 100. The higher the value the more shared decision-making
Within one week after inclusion in the consultation
The duration of consultation when PtDA is used compared to standard consultation without the use of PtDA.
大体时间：Through study completion, an average of 1 year

The time duration will be documented by the surgeons
Through study completion, an average of 1 year

其他结果措施

结果测量
措施说明
大体时间
Participant's Qol when undergoing hip or knee replacement surgery as measured by EuroQol (EQ-5D)
大体时间：Three months and one year following surgery.

QoL: EuroQol (EQ-5D): Measuring the health-related quality of life. Presenting in three levels; Level 1: Indicating no problem, to Level 3: Indicating extreme problems
Three months and one year following surgery.
The participant's pain and physical function after undergoing hip replacement surgery as measured by the Oxford Hip Score (OHS) questionnaire
大体时间：Three months and one year following surgery

Oxford Hip Score (OHS): Measuring function and pain with patients undergoing hip replacement surgery. Total scores range from 0 (poorest function) to 48 (maximal function).
Three months and one year following surgery
The participant's pain and physical function after undergoing knee replacement surgery as measured by the Oxford Knee Score (OKS) questionnaire
大体时间：Three months and one year following surgery

Oxford Knee Score (OKS): Measuring function and pain with patients undergoing knee replacement surgery. Total scores range from 0 (poorest function) to 48 (maximal function).
Three months and one year following surgery
The participant's physical function after undergoing hip or knee replacement surgery as measured by Forgotten Joint Score (FJS) questionnaire
大体时间：Three months and one year following surgery.

Forgotten joint score (FJS): Measuring the participants' awareness of their artificial joint during activity of daily living (ADL). Minimum value: 0. Maximum value: 100. The higher score, the less the patient is aware of their affected joint.
Three months and one year following surgery.
Participant's regret of the treatment decision as measured by the Decision Regret Scale questionnaire.
大体时间：Three months and one year following surgery.

The Decision Regret Scale: Minimum value: 0. Maximum value: 100. The higher the value the more regret.
Three months and one year following surgery.
Participant's satisfaction after undergoing hip or knee replacement surgery as measured by the patient satisfaction questionnaire (PSQ)
大体时间：Three months and one year following surgery.

The patient satisfaction questionnaire (PSQ): The higher the value the more satisfaction.
Three months and one year following surgery.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Vejle Hospital

合作者

Odense University Hospital

调查人员

  • 首席研究员：Trine Ahlmann, PhD stud、Vejle Hospital
  • 学习椅：Claus Varnum, Ass.Prof.MD、Vejle Hospital
  • 学习椅：Martin Lindberg-Larsen, Ass.Prof.MD.、Odense University Hospital
  • 学习椅：Charlotte Myhre Jensen, Ass.Prof.RN、Odense University Hospital
  • 学习椅：Karina Dahl Steffensen, Prof.MD.、Vejle Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年10月11日

初级完成 (实际的)

2024年11月29日

研究完成 (实际的)

2026年7月11日

研究注册日期

首次提交

2023年6月8日

首先提交符合 QC 标准的

2023年7月24日

首次发布 (实际的)

2023年8月2日

研究记录更新

最后更新发布 (实际的)

2026年9月24日

上次提交的符合 QC 标准的更新

2026年9月23日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • S-20200137

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

All data of the outcome measures will be available in an anonymized form if required by the scientific journal, in which the results of the trial will be published.

IPD 共享时间框架

Data will be available after the publication of the trial

IPD 共享访问标准

Data access will be reviewed by the author's group

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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