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

This study has been terminated.

First Received on December 21, 2007. Last Updated on December 10, 2009 History of Changes

Sponsor:	Biomet Orthopedics, LLC
Collaborator:	Lexington Clinic
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00588783

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:

MedlinePlus related topics: Knee Replacement Osteoarthritis Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

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

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:

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

Lexington Clinic

More Information

No publications provided

Responsible Party:	Dr. Christensen, Lexington Clinic
ClinicalTrials.gov Identifier:	NCT00588783 History of Changes
Other Study ID Numbers:	104-U-013
Study First Received:	December 21, 2007
Last Updated:	December 10, 2009
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 February 09, 2012