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

NCT04837053 | Completed

• 1 other identifier: Value-based TKR
• Study Type: interventional
• Target: 1,092
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• Decision quality

  Decision quality measured by DQI-Knee Osteoarthritis v2.0

  immediately after the intervention/procedure/surgery

Secondary Outcomes (2)

• Fulfillment of patient expectations

  12 months

• Oxford Knee Score (OKS)

  12 month

Study Arms (2)

Intervention cluster

EXPERIMENTAL

EKIT tool

Other: Digital decision aid for physicians and patients

Control Cluster

ACTIVE COMPARATOR

routine care

Other: Routine care

Interventions

Digital decision aid for physicians and patients OTHER

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 cluster

Routine care OTHER

Care as usual within the included study sites.

Control Cluster

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead
• Innovation Fund of the Joint Federal Committee (Gemeinsamer Bundesausschuss, G-BA), Germany: collaborator

Study Sites (1)

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

Dresden, Saxony, 01307, Germany

Location

Related Publications (2)

• 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.

  PMID: 34511058 BACKGROUND

• Lutzner J, Deckert S, Beyer F, Hahn W, Malzahn J, Sedlmayr M, Gunther KP, Schmitt J, Lange T; Value-based Total Knee Replacement Study Group. Evaluation of a Digital Decision Aid for Knee Replacement Surgery. Dtsch Arztebl Int. 2024 Aug 23;121(17):566-572. doi: 10.3238/arztebl.m2024.0152.

  PMID: 39109409 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Physicians

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Jörg Lützner, MD

  TU Dresden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic Multicenter Cluster Randomized Controlled Trial with stepped wedged design

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: April 8, 2021
• Study Start: June 1, 2021
• Primary Completion: February 28, 2023
• Study Completion: April 30, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)