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Predictors of Poor Outcomes in 1038 Sigma Knees

NCT ID: NCT01515449

Last Updated: 2012-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1038 participants

Study Classification

OBSERVATIONAL

Study Start Date

1998-10-31

Study Completion Date

2008-10-31

Brief Summary

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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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Detailed Description

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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

Conditions

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Total Knee Replacement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

All patients undergoing total knee replacement in Fife
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DePuy International

INDUSTRY

Sponsor Role collaborator

NHS Fife

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ivan Brenkel

Consultant Orthopaedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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NHS Fife

Kirkcaldy, Fife, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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IIS2010002

Identifier Type: -

Identifier Source: org_study_id

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