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What Matters to Patients With Severe Hip or Knee Osteoarthritis?

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05972525
Acronym
PATI-Project
Enrollment
615
Registered
2023-08-02
Start date
2023-10-11
Completion date
2026-07-11
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Osteoarthritis, Knee Osteoarthritis

Keywords

Hip Osteoarthritis, Knee Osteoarthritis, Shared Decision Making, Total knee arthroplasty, Partiel knee arthroplasty, Total hip arthroplasty, Decision quality, HK-DQI

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALShared 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.

Sponsors

Vejle Hospital
Lead SponsorOTHER
Odense University Hospital
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

The external statistician will be blinded and responsible for performing the analysis

Intervention model description

The group of hip and knee surgeons at Vejle, Odense, and Svendborg hospitals will be randomized 1:1 either to continue standard consultation or to practice SDM supported by the in-consultation PtDA.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
The participant's decisional quality according to The Hip/Knee Osteoarthritis Decision Quality Instrument (HK-DQI).Within one week after inclusion in the consultationInformed Patient-Centered (IPC) decision is calculated as the percentage of patients who are well-informed and received their preferred treatment.

Secondary

MeasureTime frameDescription
Participant's engagement in the decision-making process as measured by the CollaboRATE questionnaireWithin one week after inclusion in the consultationMinimum value: 0. Maximum value: 100. The higher the value the more shared decision-making
Participant's involvement in the decision-making process as measured by the HK-DQI questionnaireWithin one week after inclusion in the consultationHK-DQI, section 3, decision-making process: Minimum value: 0. Maximum value: 100. The higher the value the more shared decision-making
The duration of consultation when PtDA is used compared to standard consultation without the use of PtDA.Through study completion, an average of 1 yearThe time duration will be documented by the surgeons

Countries

Denmark

Contacts

PRINCIPAL_INVESTIGATORTrine Ahlmann, PhD stud

Vejle Hospital

STUDY_CHAIRClaus Varnum, Ass.Prof.MD

Vejle Hospital

STUDY_CHAIRMartin Lindberg-Larsen, Ass.Prof.MD.

Odense University Hospital

STUDY_CHAIRCharlotte Myhre Jensen, Ass.Prof.RN

Odense University Hospital

STUDY_CHAIRKarina Dahl Steffensen, Prof.MD.

Vejle Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026