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NCT00228137 Clinical Trial

Randomised Controlled Trial PFC Versus CKS Total Knee Prostheses

Osteoarthritis, Knee Clinical Trial

Official title:
A Prospective Randomized Double-Blind Study to Assess the Functional Differences Between the PFC and CKS Knee Prostheses

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00228137
Other study ID # HJM25577
Secondary ID FBW STRATEC 9685
Status Active, not recruiting
Phase N/A
First received September 13, 2005
Last updated August 8, 2007
Start date November 2002
Est. completion date November 2012

Study information
Verified date August 2007
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Observational

Clinical Trial Summary

The purpose of this study is to compare the functional outcome of two different total knee prostheses in a prospective randomised study.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 90
Est. completion date November 2012
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

All patients on the waiting list for a TKA due to an invalidating gonarthrose as a result of osteo-arthrosis or secondary to a rheumatic disease or a trauma.

Exclusion Criteria:

- patient suffering from juvenile rheumatic disease

- patient suffering hemophilia

- patient on the waiting list for posterior stabilized TKA or hinge joint.

- patient who suffers from a lesion of the ligaments due to surgery

- patient who is legally not capable to make decisions

- patient who suffer from cancer

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands UMC Radboud Nijmegen

Sponsors (1)
Lead Sponsor Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

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