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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04837053

Enrollment

1092

Registered

2021-04-08

Start date

2021-06-01

Completion date

2024-04-30

Last updated

2024-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Replacement, Knee, Knee Osteoarthritis

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.

Interventions

OTHERDigital 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.

OTHERRoutine care

Care as usual within the included study sites.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Pragmatic Multicenter Cluster Randomized Controlled Trial with stepped wedged design

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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)
Oxford Knee Score (OKS)	12 month	Oxford Knee Score (0 worst to 48 best)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026