NCT00734019

Survivorship of the Press Fit Condylar (P.F.C.) Sigma Fixed Bearing Knee With a Cobalt Chrome Tibial Tray

A Prospective, Non-comparative, Multicentre, Multinational Study to Determine the Survivorship of the P.F.C. Fixed Bearing Knee System Using a Moderately Cross-linked Polyethylene Insert and a Cobalt Chrome Tibial Tray.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 650 (actual)
• Sponsor: DePuy International · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study will determine the survivorship of the fixed bearing P.F.C. Sigma knee with a cobalt chrome tibial tray at 5 years.

Detailed description

The primary objective of this study is to assess the survivorship of the P.F.C. fixed bearing knee system using a cobalt chrome tibial tray and moderately cross-linked polyethylene insert at 5-Years. The secondary objectives of this investigation are to evaluate additional clinical outcomes to provide further information on the performance of the P.F.C. fixed bearing knee system using a moderately cross-linked polyethylene insert and cobalt chrome tibial tray. These outcomes will include Radiographic assessment, American Knee Society Score, Oxford Knee Score and SF-12.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	P.F.C. Sigma Knee	Orthopaedic implant for primary total knee replacement with a cobalt-chrome tibial tray and a moderately cross-linked polyethylene tibial insert

Timeline

• Start date: 2005-10-01
• Primary completion: 2019-07-03
• Completion: 2020-03-09
• First posted: 2008-08-13
• Last updated: 2021-12-01

Locations

5 sites across 3 countries: Germany, Italy, United Kingdom