The Press Fit Condylar (P.F.C.) Sigma Metal-backed Versus All-poly
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.
|Knee Osteoarthritis||Device: PFC Sigma knee with all-poly tibial component Device: PFC Sigma knee with metal backed tibia||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomised Prospective Comparison of P.F.C All-polyethylene Versus Metal-backed Tibial Component. A Clinical, Radiological and Roentgen Stereophotogrammetric Analysis (RSA) Study.|
- Using RSA it is possible to evaluate the performance of both the all-polyethylene and metal-backed tibia components to determine whether there are differences in migration between the two components [ Time Frame: 2 years ]
- Comparative evaluation of any post-operative variation between subjects receiving all-polyethylene and metal-backed tibia components in change from baseline at each post operative time points in terms of SF 12 and OKS [ Time Frame: 6 months, 1 year and 2 years ]
|Study Start Date:||October 1999|
|Study Completion Date:||March 2015|
|Primary Completion Date:||May 2005 (Final data collection date for primary outcome measure)|
1 - All Polyethylene Tibia
Total knee replacement with an all polyethylene tibial tray
Device: PFC Sigma knee with all-poly tibial component
Orthopaedic implant for total knee replacement with an all-polyethylene tibial component
Active Comparator: 2 - Poly & Metal Tibia
Total knee replacement with a metal-backed tibial component
Device: PFC Sigma knee with metal backed tibia
Orthopaedic implant for total knee replacement with a metal-backed tibial component
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733928
|Department of Orthopaedics, Freeman Hospital|
|Newcastle upon Tyne, United Kingdom, NE7 7DN|