Predictors of Poor Outcomes in 1038 Sigma Knees

This study has been completed.
De Puy International
Information provided by (Responsible Party):
Ivan Brenkel, NHS Fife Identifier:
First received: January 18, 2012
Last updated: January 23, 2012
Last verified: January 2012

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

Total Knee Replacement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictors of Poor Outcomes in 1038 Sigma Knees

Resource links provided by NLM:

Further study details as provided by NHS Fife:

Primary Outcome Measures:
  • Predictors of poor outcomes using 3 measures [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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

Enrollment: 1038
Study Start Date: October 1998
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
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


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients undergoing total knee replacement in Fife


Inclusion Criteria:

All patients undergoing total knee replacement in Fife

  Contacts and Locations
Please refer to this study by its identifier: NCT01515449

United Kingdom
NHS Fife
Kirkcaldy, Fife, United Kingdom, KY2 5AH
Sponsors and Collaborators
NHS Fife
De Puy International
  More Information

No publications provided

Responsible Party: Ivan Brenkel, Consultant Orthopaedic Surgeon, NHS Fife Identifier: NCT01515449     History of Changes
Other Study ID Numbers: IIS2010002
Study First Received: January 18, 2012
Last Updated: January 23, 2012
Health Authority: United Kingdom: National Health Service processed this record on April 14, 2014