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

Primary Purpose

Knee Osteoarthritis, Arthroplasty, Replacement, Knee

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Digital decision aid for physicians and patients
Routine care
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Center of Orthopedics, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus, Technische Universität DresdenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention cluster

Control Cluster

Arm Description

EKIT tool

routine care

Outcomes

Primary Outcome Measures

Decision quality
Decision quality measured by DQI-Knee Osteoarthritis v2.0

Secondary Outcome Measures

Fulfillment of patient expectations
Fulfillment of patient expectations measured by a 5-point Likert-scale (not at all, no, unsure, yes partially, yes completely)
Oxford Knee Score (OKS)
Oxford Knee Score (0 worst to 48 best)

Full Information

First Posted
February 22, 2021
Last Updated
March 14, 2023
Sponsor
Technische Universität Dresden
Collaborators
Innovation Fund of the Joint Federal Committee (Gemeinsamer Bundesausschuss, G-BA), Germany
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1. Study Identification

Unique Protocol Identification Number
NCT04837053
Brief Title
Implementation of Indication Criteria for Total Knee Replacement in Osteoarthritis (Value-based TKR)
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden
Collaborators
Innovation Fund of the Joint Federal Committee (Gemeinsamer Bundesausschuss, G-BA), Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Arthroplasty, Replacement, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Pragmatic Multicenter Cluster Randomized Controlled Trial with stepped wedged design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1080 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention cluster
Arm Type
Experimental
Arm Description
EKIT tool
Arm Title
Control Cluster
Arm Type
Active Comparator
Arm Description
routine care
Intervention Type
Other
Intervention Name(s)
Digital decision aid for physicians and patients
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Routine care
Intervention Description
Care as usual within the included study sites.
Primary Outcome Measure Information:
Title
Decision quality
Description
Decision quality measured by DQI-Knee Osteoarthritis v2.0
Time Frame
immediately after the intervention/procedure/surgery
Secondary Outcome Measure Information:
Title
Fulfillment of patient expectations
Description
Fulfillment of patient expectations measured by a 5-point Likert-scale (not at all, no, unsure, yes partially, yes completely)
Time Frame
12 months
Title
Oxford Knee Score (OKS)
Description
Oxford Knee Score (0 worst to 48 best)
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Franziska Beyer
Phone
+49 351 458 14173
Email
Franziska.Beyer@uniklinikum-dresden.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jörg Lützner, MD
Organizational Affiliation
TU Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Center of Orthopedics, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus, Technische Universität Dresden
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jörg Lützner, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34511058
Citation
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.
Results Reference
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Implementation of Indication Criteria for Total Knee Replacement in Osteoarthritis (Value-based TKR)

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