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NCT Number: NCT04247672

The ATtune Knee Outcome Study

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.

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Key information

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Spaarne Gasthuis

Hoofddorp, North Holland, 2134 TM, Netherlands

Location status: Recruiting

Location contact

Marjolein Schager, Registered Nurse

CONTACT

[email protected]

023 22 41673

Peter A Nolte, Orthopedic Surgeon

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Total Knee Arthroplasty (uncemented rotating platform ATTUNE)

Device

All patients receive an uncemented ATTUNE rotating platform knee system.

Other names: Total knee arthroplasty

Primary outcomes

  1. Survivorship

    Time frame: 10 year

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

  2. Complication rate

    Time frame: 10 year

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

  3. Forgotten Joint Score 12 (FJS-12)

    Time frame: 10 year

  4. Kujala Anterior Knee Pain Scale (AKPS)

    Time frame: 10 year

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

    Time frame: 10 year

    KOOS-PS

  6. Numeric Rating Scale (NRS)

    Time frame: 10 year

    NRS on pain and satisfaction

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

    Time frame: 10 year

Secondary outcomes

  1. 30 second chair stand test (30sCST)

    Time frame: 1 year

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

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

    Time frame: 1 year

    The amount of seconds one does to walk 40 meters.

  3. Stair climb test (SCT)

    Time frame: 1 year

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

  4. Tegner activity rating scale

    Time frame: 1 year

    1-item questionnaire

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

    Time frame: 1 year

    1-item questionnaire

  6. Return to work

    Time frame: 1 year

    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

  7. Alignment

    Time frame: 1 year

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

  8. Patient Health Questionnaire (PHQ-2)

    Time frame: 10 year

    2-item questionnaire to screen for major depressive episodes

  9. Pain Self Efficacy Questionnaire (PSEQ)

    Time frame: 10 year

    Questionnaire to asses pain self efficacy

  10. Pain Catastrophizing Scale (PCS)

    Time frame: 10 year

    Explores pain catastrophizing and its relation to pain behaviour

Sponsors and collaborators

Lead sponsor

Spaarne Gasthuis

Other

Registry information

Official study title

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

Acronym: ATKOS

Important dates

Study start
2020
Primary completion
2024
Study completion
2036
First posted
Jan 30, 2020
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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