Clinical trial NCT04247672: The ATtune Knee Outcome Study
Official title: The ATtune Knee Outcome Study: Prospective Evaluation of a Novel Uncemented Rotating Platform Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarthritis, Knee
Knee Osteoarthritis
Knee Rheumatism
Rheumatoid Arthritis
Lead sponsor: Spaarne Gasthuis
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 900
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with end-stage knee disease (e.g. knee osteoarthritis) warranting and able to undergo knee replacement therapy.

Brief 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. 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.

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)

Primary outcomes:
measure: Survivorship
timeFrame: 10 year
measure: Complication rate
timeFrame: 10 year
measure: Forgotten Joint Score 12 (FJS-12)
timeFrame: 10 year
measure: Kujala Anterior Knee Pain Scale (AKPS)
timeFrame: 10 year
measure: Knee injury and Osteoarthritis Outcome Scale - Physical Function Short Form
timeFrame: 10 year
measure: Numeric Rating Scale (NRS)
timeFrame: 10 year
measure: EuroQol 5 Dimensions, 3 Levels (EQ5D-3L)
timeFrame: 10 year
Secondary outcomes:
measure: 30 second chair stand test (30sCST)
timeFrame: 1 year
measure: 40m Fast paced walk test (40m-FPWT)
timeFrame: 1 year
measure: Stair climb test (SCT)
timeFrame: 1 year
measure: Tegner activity rating scale
timeFrame: 1 year
measure: University of California, Los Angeles (UCLA) activity rating scale
timeFrame: 1 year
measure: Return to work
timeFrame: 1 year
measure: Alignment
timeFrame: 1 year
measure: Patient Health Questionnaire (PHQ-2)
timeFrame: 10 year
measure: Pain Self Efficacy Questionnaire (PSEQ)
timeFrame: 10 year
measure: Pain Catastrophizing Scale (PCS)
timeFrame: 10 year
Other outcomes:
Locations:
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis
state: Noord-Holland
Study officials:
References:
citation: 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.