Clinical trial Recruiting at 1 site Observational Ages 21 to 90

Evaluating outcomes of uncemented ATTUNE knee replacements

Official title: The ATtune Knee Outcome Study: Prospective Evaluation of a Novel Uncemented Rotating Platform Total Knee Arthroplasty

Run by Spaarne Gasthuis · NCT04247672 · Data updated 2026-11-12

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 typeObservational
Ages21 Years to 90 Years
SexAll
Enrollment900 (estimated)
SponsorSpaarne Gasthuis
Academic / other
Locations1 site (Hoofddorp, North Holland)
StatusRecruiting
StartedFebruary 3, 2020
Main results expectedJanuary 22, 2024
Study endsJanuary 22, 2036
Registry record updatedApril 27, 2022
Trial IDNCT04247672 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals with end-stage knee osteoarthritis who are indicated for an ATTUNE total knee system.

Probably not a fit

Patients who require primary revision arthroplasty or have an absolute indication for cemented fixation may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: While there have been studies on cemented ATTUNE knee systems, this investigation into the uncemented version is novel and has not been previously reported.

Who can join: the full rules

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 it's running

  • Spaarne Gasthuis
    Hoofddorp, North Holland, Netherlands
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.