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Total Knee Replacement Using Simplex® or Cobalt™ Bone Cement

This study has been withdrawn prior to enrollment.
(Sponsor did not fund the study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00589485
First Posted: January 9, 2008
Last Update Posted: June 21, 2017
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.
Collaborator:
New Lexington Clinic
Information provided by (Responsible Party):
Zimmer Biomet
December 21, 2007
January 9, 2008
June 21, 2017
November 2006
November 2006   (Final data collection date for primary outcome measure)
Radiographic analysis and Knee Society Score [ Time Frame: 10 years ]
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
Total Knee Replacement Using Simplex® or Cobalt™ Bone Cement
The purpose of this study is to collect radiographic and clinical outcomes of total knee replacement using Simplex® or Cobalt™ Bone Cement.
The purpose of this study is to collect radiographic and clinical outcomes of total knee replacement using Simplex® or Cobalt™ Bone Cement.
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.
 
Withdrawn
0
November 2006
November 2006   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00589485
102-U-012
No
Not Provided
Not Provided
Zimmer Biomet
Zimmer Biomet
New Lexington Clinic
Not Provided
Zimmer Biomet
June 2017