The main purpose of this study is to record information from clinical and radiographic examinations and patient assessment questionnaires before surgery and at suitable postoperative intervals to assess the functioning and symptomology of each knee following surgery. In addition, any adverse events or complications are to be recorded, and any device failures or early revisions are to be recorded and reported directly to the Sponsor. The data are to be used in an evaluation of the performance of the P.F.C. Sigma knee implants over a minimum of 5 years.
The primary outcome measures are detailed above in the brief summary. Secondary outcomes are any adverse events or complications and any device failures or early revisions to be recorded and reported.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
723
An orthopaedic implant for total knee replacement
Princess Alexandra Hospital NHS Trust
Harlow, Essex, United Kingdom
To record information from clinical and radiographic examinations and patient assessment questionnaires before surgery and at suitable postoperative intervals
Time frame: 5 years
The secondary outcomes are any adverse events or complications are to be recorded, and any device failures or early revisions are to be recorded and reported.
Time frame: 6 weeks, 1, 2, 5 years
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