The ATtune Knee Outcome Study
Recruiting · NCT04247672 · Observational (researchers observe without assigning treatment) · Lead sponsor: Spaarne Gasthuis
View the official record on ClinicalTrials.gov →Interventions studied
Total Knee Arthroplasty (uncemented rotating platform ATTUNE)
What this trial is about
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.
Who can take part
Age range
21 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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)
Where it is running
2 locations listed.
- Spaarne Gasthuis - Hoofddorp, North Holland, Netherlands
- Spaarne Gasthuis - Hoofddorp, North Holland, Netherlands