Text Size

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
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Radiographic analysis and Knee Society Score [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: November 2006
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2015 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00589485

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

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00589485     History of Changes
Other Study ID Numbers: 102-U-012
Study First Received: December 21, 2007
Last Updated: May 1, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013