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

NCT ID: NCT01522781

Last Updated: 2012-02-01

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

234 participants

Study Classification

OBSERVATIONAL

Study Start Date

1998-10-31

Study Completion Date

2008-10-31

Brief Summary

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

Detailed Description

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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.

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. Lead investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fife Health Board

Kirkcaldy, Fife, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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IIS2010001

Identifier Type: -

Identifier Source: org_study_id

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