NCT00764803

3DKnee™ System vs. the MJS Knee System

Post-Market Study: The Efficacy of the 3DKnee™ System vs. the MJS Knee System

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 27 (actual)
• Sponsor: Encore Medical, L.P. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System in a group of 600 patients for whom data collection is already under way.

Detailed description

The purpose of this study is to compare the survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System in a group of 600 patients for whom data collection is already under way. Approximately 300 patients have already received the MJS™ knee system and data, as described below, has been collected for these patients over a period of two years. A second group of 300 patients will receive the Encore 3DKnee™ system over the next two years, and equivalent data will be collected for these individuals. A portion of the data has been collected over the past year, and now we would like to obtain permission from the patients to analyze these data as well as collect an additional year of data.

Conditions

• Rheumatoid Arthritis
• Traumatic Arthritis
• Joint Disease Secondary to Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Encore 3DKnee™ system	Subjects with rheumatoid arthritis, traumatic arthritis or osteoarthritis who were implanted with the Encore 3DKnee™ system and willing to participate in the study.
DEVICE	Encore MJS™ Knee System	Subjects with rheumatoid arthritis, traumatic arthritis or osteoarthritis who were implanted with the Encore MJS™ Knee system and willing to participate in the study.

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-11-01
• Completion: 2009-12-01
• First posted: 2008-10-02
• Last updated: 2010-03-11

Locations

1 site across 1 country: United States