Implementation of Indication Criteria for Total Knee Replacement in Osteoarthritis (Value-based TKR)

Not Applicable

Completed

• Conditions: Knee Osteoarthritis; Arthroplasty, Replacement, Knee

• Registration Number: NCT04837053
• Lead Sponsor: Technische Universität Dresden

Brief Summary

The aim of this trial is to investigate the effect of a medical decision aid (EKIT-Tool) on decision quality for knee arthroplasty.

Detailed Description

The tool will guide the SDM process and support the consultation, providing a systematic presentation of individual patient and disease-specific information and the fulfilment of indication criteria. Furthermore, it will present health information about knee replacement to empower the patient. To investigate the effect of the tool on decision quality, we choose a prospective multi-center, stepped wedge, cluster randomized controlled trial (SW-RCT) design.

Study Timeline

• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-08
• Study Start: 2021-06-01
• Primary Completion: 2023-02-28
• Study Completion: 2024-04-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1092

Inclusion Criteria

• patient with knee osteoarthritis who are candidates for knee replacement
• capacity to consent
• understanding of the German language (written and oral)
• age of 18 years or older
• informed consent

Exclusion criteria:

• meeting not all inclusion criteria

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Decision quality	immediately after the intervention/procedure/surgery	Decision quality measured by DQI-Knee Osteoarthritis v2.0

Secondary Outcome Measures

Name	Time	Method
Oxford Knee Score (OKS)	12 month	Oxford Knee Score (0 worst to 48 best)
Fulfillment of patient expectations	12 months	Fulfillment of patient expectations measured by a 5-point Likert-scale (not at all, no, unsure, yes partially, yes completely)

Trial Locations

Locations (1)

University Center of Orthopedics, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus, Technische Universität Dresden; 🇩🇪 Dresden, Saxony, Germany