Long-Term Multicenter Evaluation of the E1® Tibial Bearing

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

PROCEDURE

Total knee arthroplasty

Primary total knee arthroplasty surgery for the treatment of osteoarthritis.

Sponsors & Collaborators

• Stanford University

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Göteborg University

  collaborator OTHER

• Hospital Universitario La Paz

  collaborator OTHER

• Hvidovre University Hospital

  collaborator OTHER

• Seoul National University Hospital

  collaborator OTHER

• Ulsan University Hospital

  collaborator OTHER

• Sydney Private Hospital, Australia

  collaborator UNKNOWN

• Kennedy Center at Ascension Mercy Hospital

  collaborator OTHER

• Southern Joint Replacement Institute

  collaborator UNKNOWN

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Charles Bragdon, PhD · Massachusetts General Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

20 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-09-30

Primary Completion

2021-09-30

Completion

2021-09-30

Countries

• United States

Study Locations