Knee OsteoarthritisNCT04837053
Implementation of Indication Criteria for Total Knee Replacement in Osteoarthritis (Value-based TKR)
A study testing Digital decision aid for physicians and patients and Routine care in people with Knee Osteoarthritis and Arthroplasty, Replacement, Knee, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The aim of this trial is to investigate the effect of a medical decision aid (EKIT-Tool) on decision quality for knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Arthroplasty, Replacement, Knee
- What is being tested?
- Digital decision aid for physicians and patients and Routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,092 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2021to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- meeting not all inclusion criteria
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Center of Orthopedics, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus, Technische Universität Dresden
Dresden, Saxony, 01307
About this study
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
The aim of this trial is to investigate the effect of a medical decision aid (EKIT-Tool) on decision quality for knee arthroplasty.
Read the 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.
- Being tested
- Digital decision aid for physicians and patients, Routine care
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital decision aid for physicians and patientsOther
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.
Routine careOther
Care as usual within the included study sites.
| Study group | Role | What they receive |
|---|---|---|
| Intervention cluster | Experimental | EKIT tool Receives: Other: Digital decision aid for physicians and patients |
| Control Cluster | Active comparator | routine care Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision quality
Decision quality measured by DQI-Knee Osteoarthritis v2.0
Measured: immediately after the intervention/procedure/surgery
Secondary outcomes (2)
Fulfillment of patient expectations
Fulfillment of patient expectations measured by a 5-point Likert-scale (not at all, no, unsure, yes partially, yes completely)
Measured: 12 months
Oxford Knee Score (OKS)
Oxford Knee Score (0 worst to 48 best)
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Jun 2021
- Primary completion28 Feb 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Pragmatic Multicenter Cluster Randomized Controlled Trial with stepped wedged design
- Masking
- None (open label)
- Enrolment
- 1,092 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Gemeinsamer Bundesaussschuss
- Responsible party
- Sponsor
- Investigators
- Jörg Lützner, MD, Principal investigator, TU Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837053
- Sponsor's protocol ID
- Value-based TKR
- Status last verified
- Aug 2024
- First submitted
- 22 Feb 2021
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34511058Lutzner 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.
PubMed 39109409
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04837053
- Acronym / sponsor ID
- Value-based TKR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,092 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Gemeinsamer Bundesaussschuss
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic Multicenter Cluster Randomized Controlled Trial with stepped wedged design
| Arm | Type | Receives |
|---|---|---|
| Intervention cluster | Experimental | Other: Digital decision aid for physicians and patientsEKIT tool |
| Control Cluster | Active comparator | Other: Routine careroutine care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- meeting not all inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital decision aid for physicians and patientsThe 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. | Other | Intervention cluster |
| Routine careCare as usual within the included study sites. | Other | Control Cluster |
Primary outcome
Decision quality
Time frame: immediately after the intervention/procedure/surgery
Decision quality measured by DQI-Knee Osteoarthritis v2.0
2 secondary outcomes
Fulfillment of patient expectations
Time frame: 12 months
Oxford Knee Score (OKS)
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Background: PubMed 34511058Lange 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.
- Derived from this study: PubMed 39109409Lutzner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jörg Lützner, MD principal investigator
TU Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital decision aid for physicians and patients and Routine care in people with Knee Osteoarthritis and Arthroplasty, Replacement, Knee, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision quality (time frame: immediately after the intervention/procedure/surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04837053, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.