Long-Term Multicenter Evaluation of the E1® Tibial Bearing

Mass General Brigham

Status: Unknown

Conditions: Osteoarthritis of the Knee; Traumatic Arthritis of the Knee

Treatments: Procedure: Total knee arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT01374230

2010-P-001922

Details and patient eligibility

About

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.

Enrollment: 500 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

E1 Tibial bearing

Experimental group

Description:

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.

Treatment:

Procedure: Total knee arthroplasty