Long-Term Multicenter Evaluation of the E1® Tibial Bearing

July 26, 2018 updated by: Charles R. Bragdon, Massachusetts General Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: E1 Tibial bearing
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.
Procedure: Total knee arthroplasty
Primary total knee arthroplasty surgery for the treatment of osteoarthritis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survivorship, as determined by the implant remaining within the patient.
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Göteborg University
Seoul National University Hospital
Ulsan University Hospital
Stanford University
Hvidovre University Hospital
Aalborg University Hospital
Hospital Universitario La Paz
Sydney Private Hospital, Australia
Kennedy Center at Ascension Mercy Hospital
Southern Joint Replacement Institute

Investigators

  • Principal Investigator: Charles Bragdon, PhD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

June 14, 2011

First Submitted That Met QC Criteria

June 14, 2011

First Posted (Estimate)

June 15, 2011

Study Record Updates

Last Update Posted (Actual)

July 30, 2018

Last Update Submitted That Met QC Criteria

July 26, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-P-001922

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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