| NCT ID | NCT04247672 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Spaarne Gasthuis |
| Condition | Osteoarthritis, Knee |
| Study Type | OBSERVATIONAL |
| Enrollment | 900 participants |
| Start Date | 2020-02-03 |
| Primary Completion | 2024-01-22 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 900 participants in total. It began in 2020-02-03 with a primary completion date of 2024-01-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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)
Frequently Asked Questions
Who can join the NCT04247672 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 90 Years, studying Osteoarthritis, Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04247672 currently recruiting?
Yes, NCT04247672 is actively recruiting participants. Visit ClinicalTrials.gov or contact Spaarne Gasthuis to inquire about joining.
Where is the NCT04247672 trial being conducted?
This trial is being conducted at Hoofddorp, Netherlands.
Who is sponsoring the NCT04247672 clinical trial?
NCT04247672 is sponsored by Spaarne Gasthuis. The trial plans to enroll 900 participants.