NCT01374230

Long-Term Multicenter Evaluation of the E1® Tibial Bearing

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study has been designed to document the long-term outcome of the E1® Tibial Bearings used with the Vanguard® Knee System in 500 patients receiving total knee arthroplasty. All patients will receive the E1® Tibial Bearing in a Vanguard® knee replacement. Radiographic analysis and patient reported outcomes will be used as follow-up measures to track wear, mechanical performance, and patient satisfaction.

Conditions

• Osteoarthritis of the Knee
• Traumatic Arthritis of the Knee

Interventions

Type	Name	Description
PROCEDURE	Total knee arthroplasty	Primary total knee arthroplasty surgery for the treatment of osteoarthritis.

Timeline

• Start date: 2011-09-01
• Primary completion: 2021-09-01
• Completion: 2021-09-01
• First posted: 2011-06-15
• Last updated: 2018-07-30

Locations

1 site across 1 country: United States