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

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

Completed

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Key information

Conditions

Total Knee Replacement

Sex eligibility

All sexes

Study type

Observational

Primary location

Fife Health Board

Kirkcaldy, Fife, KY2 5AH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients undergoing total knee replacement in Fife

Treatment and study plan

Primary outcomes

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 outcomes

Radiographic outcomes at 10 years

Time frame: 10 years

looking for failure by identitying lucent lines and osteolysis

Sponsors and collaborators

Lead sponsor

NHS Fife

Other Gov

Collaborators

DePuy International

Registry information

Important dates

Study start: 1998
Primary completion: 2008
Study completion: 2008
First posted: Feb 1, 2012
Registry last updated: Feb 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed