NCT04358601

All-poly Versus Metal-backed

Migration and Survival of All-polyethylene Tibial Components Compared to the Metal-backed Modular Components of the Triathlon PS Total Knee System. A RSA Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is the assessment of prosthetic migration results after two years of the Triathlon PS Knee System with all-polyethylene tibial components compared to the Triathlon PS Knee System with metal-backed modular components by means of Roentgen Stereophotogrammetry.

Detailed description

The secondary objective will be the prediction of the long-term survival based on the two-year migration patterns combined with clinical factors and radiographic aspects. In order to identify other clinical parameters besides the fixation of the prosthesis components, clinical scores and radiographic aspects will be correlated with the RSA outcome.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Triathlon PS Knee System with all-polyethylene tibial components	Primary Total Knee Replacement
DEVICE	Triathlon PS Knee System with metal-backed modular components	Primary Total Knee Replacement

Timeline

• Start date: 2014-11-01
• Primary completion: 2017-09-17
• Completion: 2025-12-31
• First posted: 2020-04-24
• Last updated: 2025-09-04