Clinical Investigation of the Maxim® Knee System With Removable Molded Polyethylene Tibia and the Regular Maxim® Knee System
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis
Intervention: Maxim® Knee System with Removable Molded Polyethylene Tibia (Device); Regular Maxim® Knee System (Device)
Phase: N/A
Status: Completed
Sponsored by: Biomet Orthopedics, Inc. Official(s) and/or principal investigator(s):
Ken Beres, MD, Principal Investigator, Affiliation: Biomet Orthopedics, Inc.
Summary
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.
Clinical Details
Official title: A Randomized Data Collection of the Maxim® Knee System With Removable Molded Polyethylene Tibia and the Regular Maxim® Knee System
Study design: Treatment, Randomized, Open Label, Parallel Assignment
Primary outcome: Knee Society Score, Radiographic information
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Biomet Orthopedics, Inc., Warsaw, Indiana 46581, United States
Additional Information
Starting date: May 2004
Ending date: November 2007
Last updated: December 20, 2007
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