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Clinical Trials/NCT04837053
NCT04837053
Completed
Not Applicable

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

Technische Universität Dresden1 site in 1 country1,092 target enrollmentJune 1, 2021
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ConditionsKnee OsteoarthritisArthroplasty, Replacement, Knee

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Technische Universität Dresden
Enrollment
1092
Locations
1
Primary Endpoint
Decision quality
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
April 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Decision quality

Time Frame: immediately after the intervention/procedure/surgery

Decision quality measured by DQI-Knee Osteoarthritis v2.0

Secondary Outcomes

  • Fulfillment of patient expectations(12 months)
  • Oxford Knee Score (OKS)(12 month)

Study Sites (1)

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