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Total Knee Replacement With Duracon® and Vanguard™ Prostheses

This study has been terminated.
Sponsor:
Collaborator:
New Lexington Clinic
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:
NCT00588887
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 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: 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:
  • Range of motion, Knee Society Score, Duration of surgery [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: June 2005
Study Completion Date: June 2008
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

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 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:

  • Patients with infection, sepsis, or osteomyelitis.
  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
New Lexington Clinic
  More Information

No publications provided

Responsible Party: Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier: NCT00588887     History of Changes
Other Study ID Numbers: 105-U-014
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 May 21, 2013