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.
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.
Study Type
OBSERVATIONAL
Enrollment
900
All patients receive an uncemented ATTUNE rotating platform knee system.
Spaarne Gasthuis
Hoofddorp, North Holland, Netherlands
RECRUITINGSurvivorship
Calculated by determining revision rate. Septic, aseptic and all-cause revision rates will be calculated seperately.
Time frame: 10 year
Complication rate
All substantial complications associated with total knee arthroplasty will be registered and reported
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
KOOS-PS
Time frame: 10 year
Numeric Rating Scale (NRS)
NRS on pain and satisfaction
Time frame: 10 year
EuroQol 5 Dimensions, 3 Levels (EQ5D-3L)
Time frame: 10 year
30 second chair stand test (30sCST)
The amount of times one can stand up and sit down from a chair in 30 seconds
Time frame: 1 year
40m Fast paced walk test (40m-FPWT)
The amount of seconds one does to walk 40 meters.
Time frame: 1 year
Stair climb test (SCT)
The time one takes to walk a set of stairs up and down.
Time frame: 1 year
Tegner activity rating scale
1-item questionnaire
Time frame: 1 year
University of California, Los Angeles (UCLA) activity rating scale
1-item questionnaire
Time frame: 1 year
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
Time frame: 1 year
Alignment
A long-leg radiograph is performed 1 year after surgery to assess mechanical alignment of the prosthesis with consideration of femur and tibia
Time frame: 1 year
Patient Health Questionnaire (PHQ-2)
2-item questionnaire to screen for major depressive episodes
Time frame: 10 year
Pain Self Efficacy Questionnaire (PSEQ)
Questionnaire to asses pain self efficacy
Time frame: 10 year
Pain Catastrophizing Scale (PCS)
Explores pain catastrophizing and its relation to pain behaviour
Time frame: 10 year
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