NCT00733928

The Press Fit Condylar (P.F.C.) Sigma Metal-backed Versus All-poly

Randomised Prospective Comparison of P.F.C All-polyethylene Versus Metal-backed Tibial Component. A Clinical, Radiological and Roentgen Stereophotogrammetric Analysis (RSA) Study.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: DePuy International · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this investigation was to evaluate \& compare the performance of the P.F.C. Sigma Knee Cruciate-retaining all-polyethylene and metal-backed tibia components using RSA. The secondary objectives of this investigation are to evaluate the clinical and patient outcomes and survivorship associated with the P.F.C. Sigma Knee Cruciate-retaining all-polyethylene and metal-backed tibia components.

Detailed description

Using RSA, is it possible to evaluate the performance of both the all polyethylene and metal backed tibia components to determine whether there are differences in migration, if present, across the tibial components. The original protocol intended to perform clinical assessment using the Nottingham Knee Score and the Knee Society Clinical rating system pre-and post-operatively, at six months, 1 year, and annually thereafter. Per Protocol Amendment 01 (effective June 18, 1999) clinical data would also be collected via the SF-12 questionnaire. Radiological evaluation would also use the Knee Society scoring system at the same time points. However, data collected included only the SF-12 and Oxford Knee Scores, comparing change from baseline at 6, 12, and 24 months after surgery.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	PFC Sigma knee with all-poly tibial component	Orthopaedic implant for total knee replacement with an all-polyethylene tibial component
DEVICE	PFC Sigma knee with metal backed tibia	Orthopaedic implant for total knee replacement with a metal-backed tibial component

Timeline

• Start date: 1999-10-01
• Primary completion: 2005-05-01
• Completion: 2015-03-01
• First posted: 2008-08-13
• Last updated: 2025-03-30

Locations

1 site across 1 country: United Kingdom