NCT00579059

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Biomet Orthopedics, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Osteoarthritis
• Rheumatoid Arthritis
• Traumatic Arthritis

Interventions

Type	Name	Description
DEVICE	Maxim® Knee System with Removable Molded Polyethylene Tibia	Used for total knee replacements
DEVICE	Regular Maxim® Knee System	Used for total knee replacements

Timeline

• Start date: 2004-05-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2007-12-21
• Last updated: 2017-07-17
• Results posted: 2009-07-07

Locations

1 site across 1 country: United States