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

Technische Universität Dresden

Status: Completed

Conditions: Arthroplasty, Replacement, Knee; Knee Osteoarthritis

Treatments: Other: Routine care; Other: Digital decision aid for physicians and patients

Study type: Interventional

Funder types: Other

Identifiers

NCT04837053

Value-based TKR

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,092 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

1,092 participants in 2 patient groups

Intervention cluster

Experimental group

Description:

EKIT tool

Treatment:

Other: Digital decision aid for physicians and patients

Control Cluster

Active Comparator group

Description:

routine care

Treatment:

Other: Routine care