Total Knee Replacement With Duracon® and Vanguard™ Prostheses

This study has been terminated.

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

Sponsor:	Biomet Orthopedics, LLC
Collaborator:	Lexington Clinic
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00588887

Purpose

The purpose of this study is to compare range of motion, Knee Society Scores, and duration of surgery for different total knee prostheses.

Condition	Intervention
Degenerative Arthritis Osteoarthritis Rheumatoid Arthritis Knee Arthritis	Device: Duracon® Device: Vanguard™

Study Type:	Observational
Study Design:	Cohort, Prospective

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement Osteoarthritis Rheumatoid Arthritis Surgery

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

Range of motion, Knee Society Score, Duration of surgery [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	150
Study Start Date:	June 2005
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1	Device: Duracon® This group utilizes the Duracon® prostheses for total knee replacement.
2	Device: Vanguard™ This group will utilize the Vanguard™ prostheses 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 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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588887

Locations

United States, Indiana
Biomet Orthopedics, Inc.
Warsaw, Indiana, United States, 46581

Sponsors and Collaborators

Biomet Orthopedics, LLC

Lexington Clinic

More Information

No publications provided

Responsible Party:	Lexington Clinic ( Dr. Christensen )
Study ID Numbers:	105-U-014
Study First Received:	December 21, 2007
Last Updated:	December 10, 2009
ClinicalTrials.gov Identifier:	NCT00588887 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on February 08, 2010