A Clinical Randomized Controlled RSA Trial Comparing the Cemented ATTUNE Fixed Bearing Cruciate Retaining Knee System with the Cemented PFC Sigma Fixed Bearing Cruciate Retaining Knee System

Phase 4

Completed

• Conditions: Artificial Knee Joint; Total Knee Arthroplasty; 10023213

• Registration Number: NL-OMON47832
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 64

Inclusion Criteria

Age: 21- 90 years Indications: Patient is diagnosed with osteoarthritis or
rheumatoid arthritis and requiring primary knee arthroplasty

Exclusion Criteria

The patient has an a-priori risk for a posterior-stabilized total knee
arthroplasty.
Insufficiency of the posterior cruciate ligament (PCL)
Status after patellectomy
In case flexion is less than 90 degrees
When it is expected that the tibia cut during surgery will compromise the
attachment of the PCL (because of bony defects)

The patient is unable or unwilling to sign the Informed Consent specific to
this study The patient does not understand the Dutch or English language good
enough to participate Patients indicated for revision arthroplasty When there
are not enough markers visible in the baseline RSA photograph and it will not
improve by placing the patient in another position, the patient will
be excluded from the study (secondary exclusion criteria). s=fieldla

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Migration, measured by means of RSA. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Patient Reported Outcome Measures by means of questionaires. </p><br>