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I-beam and Cruciate Tibial Components Used in Total Knee Replacement

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.
ClinicalTrials.gov Identifier: NCT00588783
Recruitment Status : Terminated
First Posted : January 9, 2008
Last Update Posted : June 21, 2017
New Lexington Clinic
Information provided by (Responsible Party):
Zimmer Biomet ( Biomet Orthopedics, LLC )

Brief Summary:
The purpose of this study is to compare the clinical outcomes of using an I-beam or cruciate tibial component in total knee replacement.

Condition or disease Intervention/treatment
Degenerative Arthritis Osteoarthritis Rheumatoid Arthritis Knee Arthritis Device: I-beam design Device: Cruciate design

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : August 2006
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
1 Device: I-beam design
This group will utilize tibial components with an I-beam design for total knee replacement.
2 Device: Cruciate design
This group will utilize tibial components with cruciate designs for total knee replacement.

Primary Outcome Measures :
  1. Revision rate [ Time Frame: 10 years ]

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.

Inclusion Criteria:

  • Patients with painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartment are involved.
  • Patients requiring correction of varus, valgus, or posttraumatic deformity
  • Patients requiring correction of 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): NCT00588783

United States, Indiana
Biomet Orthopedics, LLC
Warsaw, Indiana, United States, 46581
Sponsors and Collaborators
Biomet Orthopedics, LLC
New Lexington Clinic

Responsible Party: Biomet Orthopedics, LLC
ClinicalTrials.gov Identifier: NCT00588783     History of Changes
Other Study ID Numbers: 104-U-013
First Posted: January 9, 2008    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017

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