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Predictors of Poor Outcomes in 1038 Sigma Knees

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ClinicalTrials.gov Identifier: NCT01515449
Recruitment Status : Completed
First Posted : January 24, 2012
Last Update Posted : January 24, 2012
Sponsor:
Collaborator:
DePuy International
Information provided by (Responsible Party):
Ivan Brenkel, 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.

Condition or disease
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 Type : Observational
Actual Enrollment : 1038 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictors of Poor Outcomes in 1038 Sigma Knees
Study Start Date : October 1998
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008



Primary Outcome Measures :
  1. Predictors of poor outcomes using 3 measures [ Time Frame: 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



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing total knee replacement in Fife
Criteria

Inclusion Criteria:

All patients undergoing total knee replacement in Fife


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01515449


Locations
United Kingdom
NHS Fife
Kirkcaldy, Fife, United Kingdom, KY2 5AH
Sponsors and Collaborators
NHS Fife
DePuy International

Responsible Party: Ivan Brenkel, Consultant Orthopaedic Surgeon, NHS Fife
ClinicalTrials.gov Identifier: NCT01515449     History of Changes
Other Study ID Numbers: IIS2010002
First Posted: January 24, 2012    Key Record Dates
Last Update Posted: January 24, 2012
Last Verified: January 2012