Long-term Study of The Press Fit Condylar (P.F.C.) Sigma Total Knee Replacement System
|ClinicalTrials.gov Identifier: NCT00734110|
Recruitment Status : Terminated (The study achieved the stated objective to record pre & post operative outcomes at a minimum 5 years.)
First Posted : August 13, 2008
Last Update Posted : June 9, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Device: P.F.C. Sigma Total Knee System||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||723 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multi-Centre Clinical Study of the P.F.C.® Sigma Total Knee System|
|Study Start Date :||July 2000|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||June 2010|
Experimental: P.F.C. Sigma Total Knee Replacement System
Primary total knee arthroplasty using the fixed bearing P.F.C. Sigma Total Knee Replacement System.
Device: P.F.C. Sigma Total Knee System
An orthopaedic implant for total knee replacement
Other Name: Sigma Fixed Bearing Total Knee System
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00734110
|Princess Alexandra Hospital NHS Trust|
|Harlow, Essex, United Kingdom, CM20 1QX|