What Matters to Patients With Severe Hip or Knee Osteoarthritis?

NCT05972525 | Active Not Recruiting

• 1 other identifier: S-20200137
• Study Type: interventional
• Target: 615
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (1)

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

  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

Secondary Outcomes (3)

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

  Within one week after inclusion in the consultation

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

  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.

  Through study completion, an average of 1 year

Other Outcomes (6)

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

  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

  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

  Three months and one year following surgery

Study Arms (2)

Shared decision-making (SDM)

EXPERIMENTAL

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

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

Usual practice

NO INTERVENTION

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

Interventions

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.

Shared decision-making (SDM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Vejle Hospital: lead
• Odense University Hospital: collaborator

Study Sites (3)

Odense University Hospital, OUH

Odense, 5000, Denmark

Location

Odense University Hospital, OUH

Svendborg, 5700, Denmark

Location

Lillebaelt Hospital - Vejle

Vejle, 7100, Denmark

Location

Related Publications (1)

• Pedersen TA, Lindberg-Larsen M, Jensen CM, Timm S, Steffensen KD, Varnum C. Impact of an in-consult patient decision aid on decisional quality, involvement, and health outcome for patients with severe hip or knee osteoarthritis - a study protocol for a multicentre, cluster randomised controlled trial (PATI-study). BMC Musculoskelet Disord. 2025 Jul 2;26(1):584. doi: 10.1186/s12891-025-08856-w.

  PMID: 40597226 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Trine Ahlmann, PhD stud

  Vejle Hospital

  PRINCIPAL INVESTIGATOR

• Claus Varnum, Ass.Prof.MD

  Vejle Hospital

  STUDY CHAIR

• Martin Lindberg-Larsen, Ass.Prof.MD.

  Odense University Hospital

  STUDY CHAIR

• Charlotte Myhre Jensen, Ass.Prof.RN

  Odense University Hospital

  STUDY CHAIR

• Karina Dahl Steffensen, Prof.MD.

  Vejle Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The external statistician will be blinded and responsible for performing the analysis
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: August 2, 2023
• Study Start: October 11, 2023
• Primary Completion: November 29, 2024
• Study Completion (Estimated): July 11, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available after the publication of the trial
• Access Criteria: Data access will be reviewed by the author's group

Locations

DK (3)