The ATtune Knee Outcome Study: prospective evaluation of a novel uncemented rotating platform knee system

Recruiting

• Conditions: Knee Osteoarthritis; Knee cartilage wear-and-tear; 10023213

• Registration Number: NL-OMON55973
• Lead Sponsor: Spaarne Gasthuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 900

Inclusion Criteria

End-stage osteoarthritis of the knee warranting joint replacement therapy.

Capability and willingness to sign informed consent and comply with follow-up
procedures.

Age between 21-90 years.

Capable enough in Dutch or English to be able to understand study procedures

Exclusion Criteria

An a-priori risk for a posterior-stabilized knee system (history of
patellectomy or preoperative flexion limitation <90 degrees)

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: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Survival rate and complication rate associated with the ATTUNE knee system.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Patient Reported Outcome Measures (PROMS), which are the 'Forgotten Joint<br /><br>Score 12' and the 'Kujala Anterior Knee Pain Scale' for the current study.<br /><br>- Physical function and return to sports, which is measured with 'Performance<br /><br>Based Measurments' (PBM) and 2 1-question questionnaires (Tegner and UCLA<br /><br>activity rating scale)<br /><br>- Return to work is assessed by a short self-composed questionnaire, which<br /><br>evaluates what kind of work the patients do, when they started after surgery<br /><br>and whether this is the same as their preoperative job.<br /><br>- A long-leg radiograph is performed 1 year after surgery to assess mechanical<br /><br>alignment of the prosthesis with consideration of femur and tibia.<br /><br>- Psychologic factors are assessed with 3 questionnaires preoperative, 5 years<br /><br>and 10 years postoperative (Pain Self Efficacy Questionnaire (PSEQ); Patient<br /><br>Health Questionnaire (PHQ-2); Pain Catastrophizing Scale (PCS)) </p><br>