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I-beam and Cruciate Tibial Components Used in Total Knee Replacement

This study has been terminated.
Sponsor:
Collaborator:
New Lexington Clinic
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:
NCT00588783
First received: December 21, 2007
Last updated: August 14, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of this study is to compare the clinical outcomes of using an I-beam or cruciate tibial component in total knee replacement.


Condition Intervention
Degenerative Arthritis
Osteoarthritis
Rheumatoid Arthritis
Knee Arthritis
 Device: I-beam design
Device: Cruciate design

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:
  • Revision rate [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: August 2006
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Device: I-beam design
This group will utilize tibial components with an I-beam design for total knee replacement.
2 Device: Cruciate design
This group will utilize tibial components with cruciate designs for 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 requiring total knee replacement.

Criteria

Inclusion Criteria:

  • Patients with painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartment are involved.
  • Patients requiring correction of varus, valgus, or posttraumatic deformity
  • Patients requiring correction of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

Exclusion Criteria:

  • Patients with infection, sepsis, or osteomyelitis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588783

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

No publications provided

Responsible Party: Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier: NCT00588783     History of Changes
Other Study ID Numbers: 104-U-013
Study First Received: December 21, 2007
Last Updated: August 14, 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

ClinicalTrials.gov processed this record on October 17, 2012