10 Year Outcome of Total Knee Replacement (TKR) Using Sigma Prosthesis
The purpose of this study is to obtain a prospective database which will allow analysis of total knee outcomes.
Total Knee Replacement
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||10 Year Outcome of Total Knee Replacement (TKR) Using Sigma Prosthesis|
- Clinical outcome of the Sigma knee at 10 years [ Time Frame: 10 years ] [ Designated as safety issue: No ]Patient satisfaction scores SF 12 and Oxford American Knee society score
- Radiographic outcomes at 10 years [ Time Frame: 10 years ] [ Designated as safety issue: No ]looking for failure by identitying lucent lines and osteolysis
|Study Start Date:||October 1998|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
A prospective database was set up in October 1998. Patient details are collected pre-operatively, intra-operatively and immediately post operatively. Patients are then followed up in a dedicated knee clinic at 6 months, 18 months, 3 years and 5 years. Data such as SF12 and the American knee society score has been done at each visit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522781
|Fife Health Board|
|Kirkcaldy, Fife, United Kingdom, KY2 5AH|