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Total Knee Replacement With Duracon® and Vanguard™ Prostheses

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00588887
First Posted: January 9, 2008
Last Update Posted: June 21, 2017
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.
Collaborator:
New Lexington Clinic
Information provided by (Responsible Party):
Zimmer Biomet ( Biomet Orthopedics, LLC )
  Purpose
The purpose of this study is to compare range of motion, Knee Society Scores, and duration of surgery for different total knee prostheses.

Condition Intervention
Degenerative Arthritis Osteoarthritis Rheumatoid Arthritis Knee Arthritis Device: Duracon® Device: Vanguard™

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Zimmer Biomet ( Biomet Orthopedics, LLC ):

Primary Outcome Measures:
  • Range of motion, Knee Society Score, Duration of surgery [ Time Frame: 1 year ]

Enrollment: 150
Study Start Date: June 2005
Study Completion Date: June 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Device: Duracon®
This group utilizes the Duracon® prostheses for total knee replacement.
2 Device: Vanguard™
This group will utilize the Vanguard™ prostheses for total knee replacement.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will include patients requiring total knee replacement.
Criteria

Inclusion Criteria:

  • Patients with painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
  • Patients requiring correction of varus, valgus, or posttraumatic deformity.
  • Patients requiring correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

Exclusion Criteria:

  • Patients with infection, sepsis, or osteomyelitis.
  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): NCT00588887


Locations
United States, Indiana
Biomet Orthopedics, Inc.
Warsaw, Indiana, United States, 46581
Sponsors and Collaborators
Biomet Orthopedics, LLC
New Lexington Clinic
  More Information

Responsible Party: Biomet Orthopedics, LLC
ClinicalTrials.gov Identifier: NCT00588887     History of Changes
Other Study ID Numbers: 105-U-014
First Submitted: December 21, 2007
First Posted: January 9, 2008
Last Update Posted: June 21, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases