Clinical Investigation of the Maxim® Knee System With Removable Molded Polyethylene Tibia and the Regular Maxim® Knee System - Full Text View

Clinical Investigation of the Maxim® Knee System With Removable Molded Polyethylene Tibia and the Regular Maxim® Knee System

This study has been completed.

Sponsored by:	Biomet Orthopedics, LLC
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00579059

Purpose

The purpose of this prospective clinical data collection is to document and compare the performance and clinical outcomes between the Maxim® Knee System with Removable Molded Polyethylene Tibia and the Maxim® Knee System with Modular Tibial Bearing as two treatment groups.

Condition	Intervention
Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis	Device: Maxim® Knee System with Removable Molded Polyethylene Tibia Device: Regular Maxim® Knee System

MedlinePlus related topics:

Osteoarthritis Rheumatoid Arthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment

Official Title:	A Randomized Data Collection of the Maxim® Knee System With Removable Molded Polyethylene Tibia and the Regular Maxim® Knee System

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

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

Enrollment:	200
Study Start Date:	May 2004
Study Completion Date:	November 2007

Arms	Assigned Interventions
1	Device: Maxim® Knee System with Removable Molded Polyethylene Tibia Used for total knee replacements
2	Device: Regular Maxim® Knee System Used for total knee replacements

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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: NCT00579059

Locations


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

Sponsors and Collaborators

Biomet Orthopedics, LLC

Investigators


Principal Investigator:	Ken Beres, MD	Biomet Orthopedics, LLC

More Information

Responsible Party:	Biomet Orthopedics, Inc. ( Ken Beres, MD )
Study ID Numbers:	62-U-007
First Received:	December 17, 2007
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00579059
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Autoimmune Diseases

Musculoskeletal Diseases

Osteoarthritis

Joint Diseases

Arthritis

Connective Tissue Diseases

Arthritis, Rheumatoid

Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on October 10, 2008