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Predictors of Poor Outcomes in 1038 Sigma Knees

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01515449
First Posted: January 24, 2012
Last Update Posted: January 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
DePuy International
Information provided by (Responsible Party):
Ivan Brenkel, NHS Fife
  Purpose
The aim of the project is to ascertain the pre and intra operative predictors of poor outcomes in total knee replacement.

Condition
Total Knee Replacement

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

Further study details as provided by Ivan Brenkel, NHS Fife:

Primary Outcome Measures:
  • 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


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
  Eligibility

Information from the National Library of Medicine

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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

  Contacts and Locations
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
  More Information

Responsible Party: Ivan Brenkel, Consultant Orthopaedic Surgeon, NHS Fife
ClinicalTrials.gov Identifier: NCT01515449     History of Changes
Other Study ID Numbers: IIS2010002
First Submitted: January 18, 2012
First Posted: January 24, 2012
Last Update Posted: January 24, 2012
Last Verified: January 2012