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

August 6, 2024 updated by: Technische Universität Dresden

An Individualized Decision Aid for Physicians and Patients for Total Knee Replacement in Osteoarthritis (Value-based TKR): Study Protocol for a Multi-center, Stepped Wedge, Cluster Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1092

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • University Center of Orthopedics, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus, Technische Universität Dresden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention cluster
EKIT tool
Other: Digital decision aid for physicians and patients
The intervention consists of three parts: (1) the EKIT tool provides a systematic presentation of individual patient and disease-specific information; (2) it visualizes the fulfilment of the indication criteria recommanded in corresponding german guideline; (3) it presents health information about total knee replacement.
Active Comparator: Control Cluster
routine care
Other: Routine care
Care as usual within the included study sites.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decision quality
Time Frame: immediately after the intervention/procedure/surgery
Decision quality measured by DQI-Knee Osteoarthritis v2.0
immediately after the intervention/procedure/surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Collaborators

Innovation Fund of the Joint Federal Committee (Gemeinsamer Bundesausschuss, G-BA), Germany

Investigators

  • Principal Investigator: Jörg Lützner, MD, TU Dresden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

February 22, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Value-based TKR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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