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10 Year Outcome of Total Knee Replacement (TKR) Using Sigma Prosthesis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01522781
First Posted: February 1, 2012
Last Update Posted: February 1, 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 purpose of this study is to obtain a prospective database which will allow analysis of total knee outcomes.

Condition
Total Knee Replacement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 10 Year Outcome of Total Knee Replacement (TKR) Using Sigma Prosthesis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Clinical outcome of the Sigma knee at 10 years [ Time Frame: 10 years ]
    Patient satisfaction scores SF 12 and Oxford American Knee society score


Secondary Outcome Measures:
  • Radiographic outcomes at 10 years [ Time Frame: 10 years ]
    looking for failure by identitying lucent lines and osteolysis


Enrollment: 234
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:
A prospective database was set up in October 1998. Patient details are collected pre-operatively, 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 has been done at each visit.
  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): NCT01522781


Locations
United Kingdom
Fife Health Board
Kirkcaldy, Fife, United Kingdom, KY2 5AH
Sponsors and Collaborators
NHS Fife
DePuy International
  More Information

Responsible Party: Ivan Brenkel, Consultant Orthopaedic Surgeon. Lead investigator, NHS Fife
ClinicalTrials.gov Identifier: NCT01522781     History of Changes
Other Study ID Numbers: IIS2010001
First Submitted: January 24, 2012
First Posted: February 1, 2012
Last Update Posted: February 1, 2012
Last Verified: January 2012