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Total Knee Replacement With Duracon® and Vanguard™ Prostheses

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ClinicalTrials.gov Identifier: NCT00588887
Recruitment Status : Terminated
First Posted : January 9, 2008
Last Update Posted : June 21, 2017
Sponsor:
Collaborator:
New Lexington Clinic
Information provided by (Responsible Party):
Zimmer Biomet ( Biomet Orthopedics, LLC )

Brief Summary:
The purpose of this study is to compare range of motion, Knee Society Scores, and duration of surgery for different total knee prostheses.

Condition or disease Intervention/treatment
Degenerative Arthritis Osteoarthritis Rheumatoid Arthritis Knee Arthritis Device: Duracon® Device: Vanguard™

Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : June 2005
Actual Primary Completion Date : February 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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.



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


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.

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

Responsible Party: Biomet Orthopedics, LLC
ClinicalTrials.gov Identifier: NCT00588887     History of Changes
Other Study ID Numbers: 105-U-014
First Posted: January 9, 2008    Key Record Dates
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