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

January 27, 2012 updated by: Ivan Brenkel, NHS Fife
The purpose of this study is to obtain a prospective database which will allow analysis of total knee outcomes.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

234

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Fife
      • Kirkcaldy, Fife, United Kingdom, KY2 5AH
        • Fife Health Board

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing total knee replacement in Fife

Description

Inclusion Criteria:

All patients undergoing total knee replacement in Fife

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcome of the Sigma knee at 10 years
Time Frame: 10 years
Patient satisfaction scores SF 12 and Oxford American Knee society score
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic outcomes at 10 years
Time Frame: 10 years
looking for failure by identitying lucent lines and osteolysis
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Fife

Collaborators

DePuy International

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1998

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

January 24, 2012

First Submitted That Met QC Criteria

January 27, 2012

First Posted (Estimate)

February 1, 2012

Study Record Updates

Last Update Posted (Estimate)

February 1, 2012

Last Update Submitted That Met QC Criteria

January 27, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • IIS2010001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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