RSA Cohort study

Recruiting

• Conditions: 10023213; arthrosis; knee wear

• Registration Number: NL-OMON47870
• Lead Sponsor: Spaarne Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

Patients with osteo-arthritis and or destruction of the knee joint
Patients in the age >50 years
Patient is willing to consent and participate in the study by signing and
dating an IRB-approved consent form
Patient willing to be available for follow-up evaluations through two years
post-operative

Exclusion Criteria

Patients who are unable or unwilling to cooperate in follow¬-up program
Patients who are mentally or cognitively disturbed
No written and signed Informed Consent.
Patient with a known sensitivity to materials in the device.
Revision of uni or Total Condylar knee exchange
Skeletal Immaturity
Patellectomy
Active, or local infection or systemic infection

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the stability of the prosthesis, measured with RSA.<br /><br>Stability is defined as migration (mm) and rotation (degrees) of the tibial<br /><br>component in all degrees of freedom</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Knee disability and Osteoarthritis Outcome Score (KOOS)<br /><br>Numerical Rating Scale for pain<br /><br>SF 12<br /><br>Migration and rotation at the timepoints postoperatively, 3 months, 6 months<br /><br>and 12 months postoperatively</p><br>