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Osteoarthritis, KneeATKOSNCT04247672

The ATtune Knee Outcome Study

An observational study of Osteoarthritis, Knee and Knee Osteoarthritis, run by Spaarne Gasthuis at 1 site in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To accomodate dissatisfied patients with a total knee arthroplasty (TKA) and improve outcomes, several knee systems have been developed. The cemented ATTUNE TKA shows superiority over other established knee systems at short-term, abating with longer follow-up. Read more about this study

Who is it for?
Ages 21 to 90 years
What is being tested?
Total Knee Arthroplasty (uncemented rotating platform ATTUNE)
Type of treatment
Medical device
How many people
900 participants
Where
1 siteNetherlands
Study dates
3 Feb 2020to 22 Jan 2036
Phase
Observational
Are there results?
Not yet: the study is under way

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 21 to 90 years
  • All sexes
  • Adult, Older adult

Study population: All patients with end-stage knee disease (e.g. knee osteoarthritis) warranting and able to undergo knee replacement therapy.

Who may be able to join

  • End-stage osteoarthritis of the knee warranting joint replacement therapy.
  • Indicated for an ATTUNE total knee system as part of regular clinical practice.
  • Capability and willingness to sign informed consent and comply with follow-up procedures.
  • Capable enough in Dutch or English to be able to understand study procedures

Who cannot join

  • Unable or unwilling to sign informed consent and comply with follow-up
  • Indication for primary revision arthroplasty
  • Absolute indication for cemented fixation (decreased bone stock/quality of spongiosa)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Netherlands1 site, 1 recruiting

  • Spaarne Gasthuis

    Hoofddorp, North Holland, 2134 TM

    Marjolein Schager, Registered Nurse, 023 22 41673, mschager@spaarnegasthuis.nl

    Peter A Nolte, Orthopedic Surgeon

    Recruiting

Other trials in Netherlands

About this study

Official title: The ATtune Knee Outcome Study: Prospective Evaluation of a Novel Uncemented Rotating Platform Total Knee Arthroplasty

To accomodate dissatisfied patients with a total knee arthroplasty (TKA) and improve outcomes, several knee systems have been developed. The cemented ATTUNE TKA shows superiority over other established knee systems at short-term, abating with longer follow-up. There have been no studies reporting on the results of the uncemented version of the ATTUNE. Therefore, the main objective of the current study was to report patient reported outcome measures (PROMs), survivorship and complications associated with the uncemented ATTUNE TKA.

Read the detailed description

Every year, 1.5 million total knee arthroplasties (TKA) are performed worldwide in patients whose joints have been severely affected by osteoarthritis, rheumatoid arthritis, or trauma, causing intense pain and loss of function. Due to the ageing society, these numbers are expected to have increased six-fold to 3.48 million cases annually by 2030. Even though joint replacement provides satisfactory and durable results for most patients, 20% is thought to still not be satisfied with their artificial joint. To accommodate this dissatisfied population and improve durability of implants even more, several knee systems have been developed over the years. One of the newest models is the ATTUNE knee system (DePuy, Warsaw, Indiana, USA). One of the landmark features is a gradually reducing radius in the geometry of the femoral component, more closely mimicking the anatomical patellofemoral joint and facilitating more natural femoral rollback during flexion. Comparisons of the cemented ATTUNE with previous knee systems show promising results in terms of patellofemoral outcomes, but fail to demonstrate definitive superiority in terms of all patient reported outcomes. Clinical superiority of the ATTUNE tends to abate with longer follow-up, implicating a possible superiority in the short-term recovery and return to activities. There is no follow-up study reporting the results of the uncemented ATTUNE. Moreover, all previously cited studies report better patellofemoral outcomes with patellar resurfacing, making it still unclear whether the implicated superior design changes of the femoral component hold ground without patellar resurfacing.

The primary objective is to report survivorship, complications and patient reported outcome measures associated with the uncemented ATTUNE rotating platform knee system. Secondary objectives are (1) evaluate patient reported (patellofemoral) outcomes (2) assess return to work and sport after TKA (3) translate and validate the Dutch version of the University of California, Los Angeles (UCLA) activity scale and (4) analyse psychologic factors (such as pain catastrophising and coping) and the impact on dissatisfaction following TKA.

Being tested
Total Knee Arthroplasty (uncemented rotating platform ATTUNE)
Medical subject headings
Osteoarthritis, Knee, Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Total Knee Arthroplasty (uncemented rotating platform ATTUNE)Device

    Also called Total knee arthroplasty

    All patients receive an uncemented ATTUNE rotating platform knee system.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survivorship

    Calculated by determining revision rate. Septic, aseptic and all-cause revision rates will be calculated seperately.

    Measured: 10 year

  2. Complication rate

    All substantial complications associated with total knee arthroplasty will be registered and reported

    Measured: 10 year

  3. Forgotten Joint Score 12 (FJS-12)

    Measured: 10 year

  4. Kujala Anterior Knee Pain Scale (AKPS)

    Measured: 10 year

  5. Knee injury and Osteoarthritis Outcome Scale - Physical Function Short Form

    KOOS-PS

    Measured: 10 year

  6. Numeric Rating Scale (NRS)

    NRS on pain and satisfaction

    Measured: 10 year

  7. EuroQol 5 Dimensions, 3 Levels (EQ5D-3L)

    Measured: 10 year

Secondary outcomes (10)

  1. 30 second chair stand test (30sCST)

    The amount of times one can stand up and sit down from a chair in 30 seconds

    Measured: 1 year

  2. 40m Fast paced walk test (40m-FPWT)

    The amount of seconds one does to walk 40 meters.

    Measured: 1 year

  3. Stair climb test (SCT)

    The time one takes to walk a set of stairs up and down.

    Measured: 1 year

  4. Tegner activity rating scale

    1-item questionnaire

    Measured: 1 year

  5. University of California, Los Angeles (UCLA) activity rating scale

    1-item questionnaire

    Measured: 1 year

  6. Return to work

    Assessed by a short self-composed questionnaire, which evaluates what kind of work the patients do, when they started after surgery and whether this is the same as their preoperative job

    Measured: 1 year

  7. Alignment

    A long-leg radiograph is performed 1 year after surgery to assess mechanical alignment of the prosthesis with consideration of femur and tibia

    Measured: 1 year

  8. Patient Health Questionnaire (PHQ-2)

    2-item questionnaire to screen for major depressive episodes

    Measured: 10 year

  9. Pain Self Efficacy Questionnaire (PSEQ)

    Questionnaire to asses pain self efficacy

    Measured: 10 year

  10. Pain Catastrophizing Scale (PCS)

    Explores pain catastrophizing and its relation to pain behaviour

    Measured: 10 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2020
  2. Study start3 Feb 2020
  3. Primary completion22 Jan 2024 (estimated)
  4. Study completion22 Jan 2036 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04247672
Sponsor's protocol ID
2019.0084
Acronym
ATKOS
Status last verified
Apr 2022
First submitted
20 Jan 2020
Last updated
27 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Rassir R, Sierevelt IN, Schager M, Nolte PA; ATKOS group. Design and rationale of the ATtune Knee Outcome Study (ATKOS): multicenter prospective evaluation of a novel uncemented rotating platform knee system. BMC Musculoskelet Disord. 2021 Jul 15;22(1):622. doi: 10.1186/s12891-021-04493-1.

    PubMed 34266444

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis, Knee and Knee Osteoarthritis, run by Spaarne Gasthuis at 1 site in Netherlands.

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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 27 Apr 2022. 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 Netherlands. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survivorship (time frame: 10 year). The study lists 7 primary outcomes in all. 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 NCT04247672, which also lists 1 linked publication.

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 27 Apr 2022.

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The ATtune Knee Outcome Study (NCT04247672) | AzTrials