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OpenTrials
Completed

NCT Number: NCT01515449

Predictors of Poor Outcomes in 1038 Sigma Knees

The aim of the project is to ascertain the pre and intra operative predictors of poor outcomes in total knee replacement.

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Key information

Conditions

Total Knee Replacement

Sex eligibility

All sexes

Study type

Observational

Primary location

NHS Fife

Kirkcaldy, Fife, KY2 5AH, United Kingdom

About this study

It is known that surgical outcomes are good in the majority following a Sigma knee at 5 years. 3% have persistent pain. Is it possible to predict these patients? Is it possible to make a determination as to which of the 3 outcome measures ((1) American Knee Society Score; (2) SF12 Oxford 12 and (3) Complications) is most appropriate to use and when is the most appropriate time to use it

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

  1. Predictors of poor outcomes using 3 measures

    Time frame: 10 years

    A prospective database was set up in October 1998. Patient details were collected preoperatively, 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 was done at each visit

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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
Jan 24, 2012
Registry last updated
Jan 24, 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.

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