The ATtune Knee Outcome Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-90
SponsorSpaarne Gasthuis
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 population
All patients with end-stage knee disease (e.g. knee osteoarthritis) warranting and able to undergo knee replacement therapy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Total Knee Arthroplasty (uncemented rotating platform ATTUNE)
DeviceAll patients receive an uncemented ATTUNE rotating platform knee system.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Survivorship
Calculated by determining revision rate. Septic, aseptic and all-cause revision rates will be calculated seperately.
Time frame
10 year2
Complication rate
All substantial complications associated with total knee arthroplasty will be registered and reported
Time frame
10 year3
Forgotten Joint Score 12 (FJS-12)
Time frame
10 year4
Kujala Anterior Knee Pain Scale (AKPS)
Time frame
10 yearSecondary outcomes
1
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 year2
40m Fast paced walk test (40m-FPWT)
The amount of seconds one does to walk 40 meters.
Time frame
1 year3
Stair climb test (SCT)
The time one takes to walk a set of stairs up and down.
Time frame
1 year4
Tegner activity rating scale
1-item questionnaire
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov