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NCT01522781 Clinical Trial

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

Total Knee Replacement Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01522781
Other study ID # IIS2010001
Secondary ID
Status Completed
Phase N/A
First received January 24, 2012
Last updated January 27, 2012
Start date October 1998
Est. completion date October 2008

Study information
Verified date January 2012
Source NHS Fife
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 234
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

All patients undergoing total knee replacement in Fife

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Fife Health Board Kirkcaldy Fife

Sponsors (2)
Lead Sponsor Collaborator
NHS Fife DePuy International

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical outcome of the Sigma knee at 10 years Patient satisfaction scores SF 12 and Oxford American Knee society score 10 years No
Secondary Radiographic outcomes at 10 years looking for failure by identitying lucent lines and osteolysis 10 years No
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