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

Study Type: Observational

Study Design: Cohort, Prospective

Study Primary Completion Date: September 2015

Intervention(s) in this Clinical Trial

• Device: I-beam design
  • This group will utilize tibial components with an I-beam design for total knee replacement.
• Device: Cruciate design
  • This group will utilize tibial components with cruciate designs for total knee replacement.

Arms, Groups and Cohorts in this Clinical Trial

• : 1
• : 2

Primary Measures

• Revision rate
  • Time Frame: 10 years
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Biomet Orthopedics, LLC

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00588783

Study ID Number: 104-U-013

ClinicalTrials.gov Identifier: NCT00588783

Health Authority: United States: Institutional Review Board