NCT03494348

RSA Study of Persona TKA With CR vs MC Polyethylene

Aspects of Alignment, Function, and Migration Behaviour in Two Conceptually Different Articular Surface Designs in the Cruciate Retaining Version of the Cemented Persona Knee System - A Randomized Study Evaluated by RSA and CT Analysis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate, over a 2 year period, the migration pattern, function and the possibility of anatomical reconstruction of a relatively new total knee arthroplasty (TKA) concept, the Persona. Sixty patients will be randomized into 2 groups of 30 patients each, with one group receiving the Persona TKA with a conventional Cruciate Retaining (CR) polyethylene articular surface and the other group with a newly developed Medial Congruent (MC) articular surface. Patients will be followed up with Radiostereometry (RSA), conventional radiography, outcome questionnaires, clinical evaluation and Computer Tomography (CT). The migration pattern of the components will be evaluated as well as the degree of anatomical reconstruction and clinical result. We plan also to do a 5 year follow-up of the patients with RSA and PROMS.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	Medial Congruent Polyethylene (MC)	One group receives the conventional CR surface and the other the new MC articular surface

Timeline

• Start date: 2017-10-01
• Primary completion: 2020-10-30
• Completion: 2023-12-01
• First posted: 2018-04-11
• Last updated: 2022-11-29

Locations

1 site across 1 country: Sweden

Regulatory

• FDA-regulated device study