Predictors of Poor Outcomes in 1038 Sigma Knees

Total Knee Replacement Clinical Trial

Official title:

Predictors of Poor Outcomes in 1038 Sigma Knees

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01515449
• Other study ID #: IIS2010002
• Status: Completed
• Phase: N/A
• First received: January 18, 2012
• Last updated: January 23, 2012
• Start date: October 1998
• Est. completion date: October 2008

Study information

• Verified date: January 2012
• Source: NHS Fife
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1038
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

All patients undergoing total knee replacement in Fife

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Total Knee Replacement

Locations

Country	Name	City	State
United Kingdom	NHS Fife	Kirkcaldy	Fife

Sponsors (2)

Lead Sponsor	Collaborator
NHS Fife	DePuy International

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictors of poor outcomes using 3 measures	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	10 years	No