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

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ClinicalTrials.gov Identifier: NCT01522781
Recruitment Status : Completed
First Posted : February 1, 2012
Last Update Posted : February 1, 2012
Sponsor:
Collaborator:
DePuy International
Information provided by (Responsible Party):
Ivan Brenkel, NHS Fife

Brief Summary:
The purpose of this study is to obtain a prospective database which will allow analysis of total knee outcomes.

Condition or disease
Total Knee Replacement

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.

Study Type : Observational
Actual Enrollment : 234 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 10 Year Outcome of Total Knee Replacement (TKR) Using Sigma Prosthesis
Study Start Date : October 1998
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  1. Radiographic outcomes at 10 years [ Time Frame: 10 years ]
    looking for failure by identitying lucent lines and osteolysis



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


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

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