The ATtune Knee Outcome Study
Recruiting
- Conditions
- Knee Osteoarthritis
- Registration Number
- NL-OMON28720
- Lead Sponsor
- Spaarne Gasthuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 900
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)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survivorship: Calculated by determining revision rate. Septic, aseptic and all-cause revision rates will be calculated seperately.<br><br>Complication rate: All substantial complications associated with total knee arthroplasty will be registered and reported<br><br>Forgotten Joint Score 12 (FJS-12)<br><br>Kujala Anterior Knee Pain Scale (AKPS)<br><br>Knee injury and Osteoarthritis Outcome Scale - Physical Function Short Form<br><br>KOOS-PS<br><br>Numeric Rating Scale (NRS): NRS on pain and satisfaction<br><br>EuroQol 5 Dimensions, 3 Levels (EQ5D-3L)
- Secondary Outcome Measures
Name Time Method