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Completed

NCT Number: NCT04837053

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

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

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Key information

Conditions

Knee Osteoarthritis Arthritis Arthroplasty, Replacement, Knee Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Dresden, Saxony, 01307, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Digital decision aid for physicians and patients

Other

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.

Routine care

Other

Care as usual within the included study sites.

Primary outcomes

  1. Decision quality

    Time frame: immediately after the intervention/procedure/surgery

    Decision quality measured by DQI-Knee Osteoarthritis v2.0

Secondary outcomes

  1. 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)

  2. Oxford Knee Score (OKS)

    Time frame: 12 month

    Oxford Knee Score (0 worst to 48 best)

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • Gemeinsamer Bundesaussschuss

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Apr 8, 2021
Registry last updated
Aug 7, 2024

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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