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: July 22, 2013
Last verified: July 2013
  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:


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
Study Completion Date: October 2008
Primary Completion Date: October 2008 (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
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, see Learn About Clinical Studies.

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: July 22, 2013
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 August 01, 2014