10 Year Outcome of Total Knee Replacement (TKR) Using Sigma Prosthesis

Completed

• Conditions: Total Knee Replacement

• Registration Number: NCT01522781
• Lead Sponsor: NHS Fife

Brief Summary

The purpose of this study is to obtain a prospective database which will allow analysis of total knee outcomes.

Detailed Description

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.

Study Timeline

• Study Start: 1998-10
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2012-01
• Study First Submitted: 2012-01-24
• Study First Submitted QC: 2012-01-27
• Last Update Submitted: 2012-01-27
• Study First Posted: 2012-02-01
• Last Update Posted: 2012-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

All patients undergoing total knee replacement in Fife

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical outcome of the Sigma knee at 10 years	10 years	Patient satisfaction scores SF 12 and Oxford American Knee society score

Secondary Outcome Measures

Name	Time	Method
Radiographic outcomes at 10 years	10 years	looking for failure by identitying lucent lines and osteolysis

Trial Locations

Locations (1)

Fife Health Board; 🇬🇧 Kirkcaldy, Fife, United Kingdom