Maxim® Knee Pop-Top® Tibia vs. Regular Maxim® Knee Tibia

Rheumatoid Arthritis Clinical Trial

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

Status Terminated

Clinical Trial Summary

The purpose of this prospective clinical data collection is to compare the outcomes of two different tibial bearings: the Maxim® Pop-Top® Tibia and Maxim® Modular Tibia.

Clinical Trial Description

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 Poly Tibia and the Maxim® Knee System with Modular Tibial Bearing as two treatment groups.

FDA has cleared these devices via Premarket Notification 510(k)'s K991753, K984623, K993159, K010027. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts and answer potential questions from reimbursement agencies. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Osteoarthritis
• Rheumatoid Arthritis
• Traumatic Arthritis

• NCT number: NCT00579059
• Study type: Interventional
• Source: Biomet, Inc.
• Status: Terminated
• Phase: N/A
• Start date: May 2004
• Completion date: November 2007