No registrations found.
ID
Source
Brief title
Health condition
Knee Osteoarthritis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Survivorship: Calculated by determining revision rate. Septic, aseptic and all-cause revision rates will be calculated seperately.
Complication rate: All substantial complications associated with total knee arthroplasty will be registered and reported
Forgotten Joint Score 12 (FJS-12)
Kujala Anterior Knee Pain Scale (AKPS)
Knee injury and Osteoarthritis Outcome Scale - Physical Function Short Form
KOOS-PS
Numeric Rating Scale (NRS): NRS on pain and satisfaction
EuroQol 5 Dimensions, 3 Levels (EQ5D-3L)
Secondary outcome
30 second chair stand test (30sCST): The amount of times one can stand up and sit down from a chair in 30 seconds
40m Fast paced walk test (40m-FPWT): The amount of seconds one does to walk 40 meters.
Stair climb test (SCT): The time one takes to walk a set of stairs up and down.
Tegner activity rating scale: 1-item questionnaire
University of California, Los Angeles (UCLA) activity rating scale: 1-item questionnaire
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
Alignment: A long-leg radiograph is performed 1 year after surgery to assess mechanical alignment of the prosthesis with consideration of femur and tibia
Patient Health Questionnaire (PHQ-2): 2-item questionnaire to screen for major depressive episodes
Pain Self Efficacy Questionnaire (PSEQ): Questionnaire to asses pain self efficacy
Pain Catastrophizing Scale (PCS): Explores pain catastrophizing and its relation to pain behaviour
Background 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.
Study objective
Compared with other well-established knee designs, the uncemented rotating platform ATTUNE knee system has similar outcomes regarding survivorship and complications, but may have improved early recovery.
Study design
1 year, 5 years and 10 years
Intervention
Total knee arthroplasty (TKA) with the uncemented ATTUNE rotating platform.
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)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8929 |
| CCMO | NL71274.029.19 |
| OMON | NL-OMON55973 |