The Persona Partial Knee - an RSA study

Not Applicable

Completed

• Conditions: Persona Partial Knee, RSA, Knee, Unicondylar; 10023213

• Registration Number: NL-OMON20822
• Lead Sponsor: Zimmer Biomet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

Indications for PPK prosthesis specifically:

• Noninflammatory degenerative joint disease (NIDJD), e.g. osteoarthritis, avascular necrosis

Exclusion Criteria

Contra-indications for PPK prosthesis specifically:

• Infection, sepsis, and osteomyelitis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Fixation and migration patterns of the PPK prosthesis in vivo, using model-based RSA.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Short- and midterm clinical results by means of:<br /><br>• Numeric Rating Scale (NRS) for pain<br /><br>• Range of Motion (ROM)<br /><br>• Knee injury and Osteoarthritis Outcome Score (KOOS-PS)<br /><br>• Oxford Knee Score (OKS)<br /><br>• EuroQoL-5D (EQ-5D)<br /><br>• Radiographs</p><br>