Predictors of Poor Outcomes in 1038 Sigma Knees

Completed

• Conditions: Total Knee Replacement

• Registration Number: NCT01515449
• Lead Sponsor: NHS Fife

Brief Summary

The aim of the project is to ascertain the pre and intra operative predictors of poor outcomes in total knee replacement.

Detailed Description

It is known that surgical outcomes are good in the majority following a Sigma knee at 5 years. 3% have persistent pain. Is it possible to predict these patients? Is it possible to make a determination as to which of the 3 outcome measures ((1) American Knee Society Score; (2) SF12 Oxford 12 and (3) Complications) is most appropriate to use and when is the most appropriate time to use it

Study Timeline

• Study Start: 1998-10
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2012-01
• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-23
• Last Update Submitted: 2012-01-23
• Study First Posted: 2012-01-24
• Last Update Posted: 2012-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1038

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
Predictors of poor outcomes using 3 measures	10 years	A prospective database was set up in October 1998. Patient details were collected preoperatively, 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 was done at each visit

Trial Locations

Locations (1)

NHS Fife; 🇬🇧 Kirkcaldy, Fife, United Kingdom