Total Knee Replacement Using Simplex® or Cobalt™ Bone Cement

This study has been terminated.
Sponsor:
Collaborator:
New Lexington Clinic
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00589485
First received: December 21, 2007
Last updated: May 1, 2012
Last verified: May 2012

December 21, 2007
May 1, 2012
November 2006
November 2015   (final data collection date for primary outcome measure)
Radiographic analysis and Knee Society Score [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00589485 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Total Knee Replacement Using Simplex® or Cobalt™ Bone Cement
Not Provided

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

The study population will include patients who require total knee replacement.

  • Osteoarthritis
  • Rheumatoid Arthritis
  • Traumatic Arthritis
  • Knee Arthritis
  • 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.
  • 1
    Intervention: Device: Simplex® Bone Cement
  • 2
    Intervention: Device: Cobalt™ Bone Cement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
100
November 2017
November 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00589485
102-U-012
No
Biomet, Inc.
Biomet, Inc.
New Lexington Clinic
Not Provided
Biomet, Inc.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP