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

Knee Osteoarthritis Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04837053
• Other study ID #: Value-based TKR
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2024
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1092
• Est. completion date: April 30, 2024
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee
• Knee Osteoarthritis
• Osteoarthritis

Intervention

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.
• Routine care
Care as usual within the included study sites.

Locations

Country	Name	City	State
Germany	University Center of Orthopedics, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus, Technische Universität Dresden	Dresden	Saxony

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität Dresden	Innovation Fund of the Joint Federal Committee (Gemeinsamer Bundesausschuss, G-BA), Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Lange T, Deckert S, Beyer F, Hahn W, Einhart N, Roessler M, Sedlmayr M, Schmitt J, Lutzner J. An individualized decision aid for physicians and patients for total knee replacement in osteoarthritis (Value-based TKR study): study protocol for a multi-center, stepped wedge, cluster randomized controlled trial. BMC Musculoskelet Disord. 2021 Sep 12;22(1):783. doi: 10.1186/s12891-021-04546-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decision quality	Decision quality measured by DQI-Knee Osteoarthritis v2.0	immediately after the intervention/procedure/surgery
Secondary	Fulfillment of patient expectations	Fulfillment of patient expectations measured by a 5-point Likert-scale (not at all, no, unsure, yes partially, yes completely)	12 months
Secondary	Oxford Knee Score (OKS)	Oxford Knee Score (0 worst to 48 best)	12 month