Total Knee Replacement Using Simplex® or Cobalt™ Bone Cement

This study is ongoing, but not recruiting participants.

First Received: December 21, 2007 Last Updated: July 3, 2008 History of Changes

Sponsored by:	Biomet Orthopedics, LLC
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00589485

Purpose

The purpose of this study is to collect radiographic and clinical outcomes of total knee replacement using Simplex® or Cobalt™ Bone Cement.

Condition	Intervention
Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis Knee Arthritis	Device: Simplex® Bone Cement Device: Cobalt™ Bone Cement

MedlinePlus related topics: Knee Replacement Osteoarthritis Rheumatoid Arthritis

Drug Information available for: Cobalt

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

Radiographic analysis and Knee Society Score [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	100
Study Start Date:	November 2006
Estimated Study Completion Date:	November 2017
Estimated Primary Completion Date:	November 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1	Device: Simplex® Bone Cement This arm will utilize Simplex® Bone Cement in total knee replacement.
2	Device: Cobalt™ Bone Cement This arm utilizes Cobalt™ Bone Cement in 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 who require 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:

Infection, sepsis, and osteomyelitis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589485

Locations

United States, Indiana
Biomet Orthopedics, LLC
Warsaw, Indiana, United States, 46581

Sponsors and Collaborators

Biomet Orthopedics, LLC

More Information

No publications provided

Responsible Party:	Biomet Orthopedics, Inc. ( Kenneth J. Beres, MD, Director of Clinical Research )
Study ID Numbers:	102-U-012
Study First Received:	December 21, 2007
Last Updated:	July 3, 2008
ClinicalTrials.gov Identifier:	NCT00589485 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Osteoarthritis
Cobalt
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Trace Elements
Micronutrients
Rheumatic Diseases

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Osteoarthritis
Joint Diseases
Growth Substances
Physiological Effects of Drugs
Arthritis, Rheumatoid
Trace Elements

Rheumatic Diseases
Pharmacologic Actions
Musculoskeletal Diseases
Arthritis
Cobalt
Connective Tissue Diseases
Micronutrients

ClinicalTrials.gov processed this record on May 07, 2009