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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This study has been withdrawn prior to enrollment.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
  Purpose
The purpose of this study is to collect radiographic and clinical outcomes of total knee replacement using Simplex® or Cobalt™ Bone Cement.

Condition Intervention
Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis Knee Arthritis Device: Simplex® Bone Cement Device: Cobalt™ Bone Cement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Total Knee Replacement Using Simplex® or Cobalt™ Bone Cement

Resource links provided by NLM:


Further study details as provided by Zimmer Biomet:

Primary Outcome Measures:
  • Radiographic analysis and Knee Society Score [ Time Frame: 10 years ]

Enrollment: 0
Study Start Date: November 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Device: Simplex® Bone Cement
This arm will utilize Simplex® Bone Cement in total knee replacement.
2 Device: Cobalt™ Bone Cement
This arm utilizes Cobalt™ Bone Cement in total knee replacement.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will include patients who require total knee replacement.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00589485


Locations
United States, Indiana
Biomet Orthopedics, LLC
Warsaw, Indiana, United States, 46581
Sponsors and Collaborators
Zimmer Biomet
New Lexington Clinic
  More Information

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00589485     History of Changes
Other Study ID Numbers: 102-U-012
First Submitted: December 21, 2007
First Posted: January 9, 2008
Last Update Posted: June 21, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Cobalt
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs