Total Knee Replacement Using Simplex® or Cobalt™ Bone Cement

Verified by: Biomet, Inc., December 2009
First Received: December 21, 2007 | Last Updated: December 10, 2009 | Phase: N/A | Start Date: November 2006
Overall Status: Terminated | Estimated Enrollment: 100
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The purpose of this study is to collect radiographic and clinical outcomes of total knee replacement using Simplex® or Cobalt™ Bone Cement...

Brief Summary

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: Observational Model: Cohort, Time Perspective: 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

Outcome Measures for this Clinical Trial

Primary Measures

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Biomet, Inc. Industry

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00589485