Long-Term Multicenter Evaluation of the E1® Tibial Bearing

Not Applicable

• Conditions: Osteoarthritis of the Knee; Traumatic Arthritis of the Knee
• Interventions: Procedure: Total knee arthroplasty

• Registration Number: NCT01374230
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-14
• Study First Submitted QC: 2011-06-14
• Study First Posted: 2011-06-15
• Study Start: 2011-09
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-26
• Last Update Posted: 2018-07-30
• Primary Completion: 2021-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Male or Female
• 20 to 75 years of age
• Subjects requiring total knee replacement
• Subjects with the diagnosis of osteoarthritis, or traumatic arthritis
• Subjects who demonstrate the ability to return to Massachusetts General Hospital for follow-up for the next 10 years

Exclusion Criteria

• Subjects with osteoporosis, osteomalacia, or neuromuscular disease
• Incomplete or insufficient soft tissue around the knee
• Subjects with a limited life span
• Subjects who have difficulty comprehending the study protocol for any reason
• Subjects with disorders which may impair bone formation
• Subjects whose bony structure deviates substantially from the general norm
• Female subjects that are, or may become, pregnant while participating in this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
E1 Tibial bearing	Total knee arthroplasty	All patients undergoing primary total knee replacement surgery will receive a tibial bearing made of E1 polyethylene, which is the material being monitored in this study.

Primary Outcome Measures

Name	Time	Method
Survivorship, as determined by the implant remaining within the patient.	10 years

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States