Evaluating outcomes of uncemented ATTUNE knee replacements
The ATtune Knee Outcome Study: Prospective Evaluation of a Novel Uncemented Rotating Platform Total Knee Arthroplasty
This study is testing how well the uncemented ATTUNE knee replacement works for people with severe knee arthritis and how satisfied they are with the results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 900 (estimated) |
| Ages | 21 Years to 90 Years |
| Sex | All |
| Sponsor | Spaarne Gasthuis Academic / other |
| Locations | 1 site (Hoofddorp, North Holland) |
| Trial ID | NCT04247672 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the patient-reported outcomes, survivorship, and complications associated with the uncemented ATTUNE total knee arthroplasty (TKA) in patients suffering from end-stage knee osteoarthritis. With an increasing number of knee replacements performed annually, the study focuses on a specific population that has not been extensively studied before. By comparing the uncemented ATTUNE with existing knee systems, the research seeks to provide insights into its effectiveness and patient satisfaction over time. Participants will be monitored for their recovery and overall satisfaction with the procedure.
Who should consider this trial
Good fit: Ideal candidates include individuals with end-stage knee osteoarthritis who are indicated for an ATTUNE total knee system.
Not a fit: Patients who require primary revision arthroplasty or have an absolute indication for cemented fixation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and satisfaction for patients undergoing knee replacement surgery.
How similar studies have performed: While there have been studies on cemented ATTUNE knee systems, this investigation into the uncemented version is novel and has not been previously reported.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Hoofddorp, North Holland
- Spaarne Gasthuis — Hoofddorp, North Holland, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.