Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04837053
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2021-02-22
Brief Title:
Implementation of Indication Criteria for Total Knee Replacement in Osteoarthritis Value-based TKR
Sponsor:
Technische Universität Dresden
Organization:
Technische Universität Dresden
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None