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Randomised Controlled Trial PFC Versus CKS Total Knee Prostheses

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2007 by Radboud University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00228137
First Posted: September 28, 2005
Last Update Posted: August 9, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Radboud University
  Purpose
The purpose of this study is to compare the functional outcome of two different total knee prostheses in a prospective randomised study.

Condition
Osteoarthritis, Knee

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: A Prospective Randomized Double-Blind Study to Assess the Functional Differences Between the PFC and CKS Knee Prostheses

Further study details as provided by Radboud University:

Estimated Enrollment: 90
Study Start Date: November 2002
Estimated Study Completion Date: November 2012
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00228137


Locations
Netherlands
UMC Radboud
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
Study Chair: Maarten MC de Waal Malefijt, MD Radboud University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00228137     History of Changes
Other Study ID Numbers: HJM25577
FBW STRATEC 96856
First Submitted: September 13, 2005
First Posted: September 28, 2005
Last Update Posted: August 9, 2007
Last Verified: August 2007

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases


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