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Recruiting NCT04247672

The ATtune Knee Outcome Study

Observational Osteoarthritis, Knee Knee Osteoarthritis Knee Rheumatism Rheumatoid Arthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Total Knee Arthroplasty (uncemented rotating platform ATTUNE).
Who it may be relevant to
Registry conditions: Osteoarthritis, Knee, Knee Osteoarthritis, Knee Rheumatism, Rheumatoid Arthritis. Basic parameters: 21 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Device Total Knee Arthroplasty (uncemented rotating platform ATTUNE)
    All patients receive an uncemented ATTUNE rotating platform knee system.

Primary outcome measures

  • Survivorship [Time frame: 10 year]
  • Complication rate [Time frame: 10 year]
  • Forgotten Joint Score 12 (FJS-12) [Time frame: 10 year]
  • Kujala Anterior Knee Pain Scale (AKPS) [Time frame: 10 year]
  • Knee injury and Osteoarthritis Outcome Scale - Physical Function Short Form [Time frame: 10 year]
  • Numeric Rating Scale (NRS) [Time frame: 10 year]
  • EuroQol 5 Dimensions, 3 Levels (EQ5D-3L) [Time frame: 10 year]
Secondary outcome measures (10)
  • 30 second chair stand test (30sCST) [Time frame: 1 year]
  • 40m Fast paced walk test (40m-FPWT) [Time frame: 1 year]
  • Stair climb test (SCT) [Time frame: 1 year]
  • Tegner activity rating scale [Time frame: 1 year]
  • University of California, Los Angeles (UCLA) activity rating scale [Time frame: 1 year]
  • Return to work [Time frame: 1 year]
  • Alignment [Time frame: 1 year]
  • Patient Health Questionnaire (PHQ-2) [Time frame: 10 year]
  • Pain Self Efficacy Questionnaire (PSEQ) [Time frame: 10 year]
  • Pain Catastrophizing Scale (PCS) [Time frame: 10 year]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Netherlands · 1 center
  • Spaarne Gasthuis — Hoofddorp

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. PMID 34266444

Identifiers

NCT: NCT04247672 · 2019.0084

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗