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

This study has been completed.
DePuy 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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 
Study First Received: January 24, 2012
Last Updated: January 27, 2012
Health Authority: United Kingdom: National Health Service

ClinicalTrials.gov processed this record on May 26, 2016