The purpose of this study is to evaluate the long-term clinical and functional performance of the P.F.C. Sigma Rotating Platform TC3 knee system in revision knee surgery and to determine whether the implant design results in a longer-lasting knee replacement.
Primary outcome: Implant survival at 5 years Secondary Outcomes:Evidence of clinical and functional outcome determined by the Knee Society Score, anterior knee pain (Patellar Score). Evidence of health related quality of life determined by WOMAC OA index. Patient satisfaction at 1 and 5 years. Radiographic analysis according to Knee society guidelines. Implant survival annually to 15 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
181
Orthopaedic implant system for revision total knee replacement
CHU
Amiens, France
Orthopaedische Universitaetsklinik
Heidelberg, Germany
Asklepios Klinik
Lindenlohe, Germany
Geneva University Hospital
Geneva, Switzerland
Implant survival
Time frame: 5 years
Clinical/functional outcome (Knee Society & Patellar Scores). Health-related QoL (WOMAC OA Index). Patient Satisfaction at 1 & 5 years (2 patient questions). Radiographic analysis (Knee Society guidelines). Annual implant survival to 15 years.
Time frame: 6 months, 1, 2, 3, 5, 10 and 15 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Princess Alexandra Hospital NHS Site
Harlow, Essex, United Kingdom
City Hospital
Nottingham, Nottinghamshire, United Kingdom
Western Infirmary
Glasgow, United Kingdom
Leicester General Infirmary
Leicester, United Kingdom
Robert Jones & Agnes Hunt Orthopaedic Hospital
Oswestry, United Kingdom