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

This study has been completed.
De Puy International
Information provided by (Responsible Party):
Ivan Brenkel, NHS Fife
ClinicalTrials.gov Identifier:
First received: January 24, 2012
Last updated: January 27, 2012
Last verified: January 2012

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

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 NHS Fife:

Primary Outcome Measures:
  • Clinical outcome of the Sigma knee at 10 years [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Patient satisfaction scores SF 12 and Oxford American Knee society score

Secondary Outcome Measures:
  • Radiographic outcomes at 10 years [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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.


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 ClinicalTrials.gov identifier: NCT01522781

United Kingdom
Fife Health Board
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. Lead investigator, NHS Fife
ClinicalTrials.gov Identifier: NCT01522781     History of Changes
Other Study ID Numbers: IIS2010001
Study First Received: January 24, 2012
Last Updated: January 27, 2012
Health Authority: United Kingdom: National Health Service

ClinicalTrials.gov processed this record on April 17, 2014