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NCT Number: NCT05972525

What Matters to Patients With Severe Hip or Knee Osteoarthritis?

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hip Osteoarthritis Arthritis Joint Diseases Knee Osteoarthritis Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital, OUH, Odense, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Shared decision-making supported by an in-consultation PtDA to patients with severe osteoarthritis in their hip or knee

Behavioral

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.

Primary outcomes

  1. The participant's decisional quality according to The Hip/Knee Osteoarthritis Decision Quality Instrument (HK-DQI).

    Time frame: 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.

Secondary outcomes

  1. Participant's engagement in the decision-making process as measured by the CollaboRATE questionnaire

    Time frame: Within one week after inclusion in the consultation

    Minimum value: 0. Maximum value: 100. The higher the value the more shared decision-making

  2. Participant's involvement in the decision-making process as measured by the HK-DQI questionnaire

    Time frame: 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

  3. The duration of consultation when PtDA is used compared to standard consultation without the use of PtDA.

    Time frame: Through study completion, an average of 1 year

    The time duration will be documented by the surgeons

Other outcomes

  1. Participant's Qol when undergoing hip or knee replacement surgery as measured by EuroQol (EQ-5D)

    Time frame: 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

  2. The participant's pain and physical function after undergoing hip replacement surgery as measured by the Oxford Hip Score (OHS) questionnaire

    Time frame: 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).

  3. The participant's pain and physical function after undergoing knee replacement surgery as measured by the Oxford Knee Score (OKS) questionnaire

    Time frame: 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).

  4. The participant's physical function after undergoing hip or knee replacement surgery as measured by Forgotten Joint Score (FJS) questionnaire

    Time frame: 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.

  5. Participant's regret of the treatment decision as measured by the Decision Regret Scale questionnaire.

    Time frame: Three months and one year following surgery.

    The Decision Regret Scale: Minimum value: 0. Maximum value: 100. The higher the value the more regret.

  6. Participant's satisfaction after undergoing hip or knee replacement surgery as measured by the patient satisfaction questionnaire (PSQ)

    Time frame: Three months and one year following surgery.

    The patient satisfaction questionnaire (PSQ): The higher the value the more satisfaction.

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Collaborators

  • Odense University Hospital

Registry information

Official study title

What Matters to Patients With Severe Hip or Knee Osteoarthritis? Decisional Quality, Patient Involvement and Health Outcome

Acronym: PATI-Project

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Aug 2, 2023
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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