The purpose of this study is to collect radiographic and clinical outcomes of total knee replacement using Simplex® or Cobalt™ Bone Cement.

Study Type: Observational

Study Design: Cohort, Prospective

Study Primary Completion Date: November 2015

Intervention(s) in this Clinical Trial

• Device: Simplex® Bone Cement
  • This arm will utilize Simplex® Bone Cement in total knee replacement.
• Device: Cobalt™ Bone Cement
  • This arm utilizes Cobalt™ Bone Cement in total knee replacement.

Arms, Groups and Cohorts in this Clinical Trial

• : 1
• : 2

Primary Measures

• Radiographic analysis and Knee Society Score
  • Time Frame: 10 years
    Safety Issue?: No

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:

• Infection, sepsis, and 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, Inc.

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00589485

Study ID Number: 102-U-012

ClinicalTrials.gov Identifier: NCT00589485

Health Authority: United States: Institutional Review Board