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Long-Term Multicenter Evaluation of the E1® Tibial Bearing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01374230
Recruitment Status : Active, not recruiting
First Posted : June 15, 2011
Last Update Posted : May 3, 2017
Information provided by (Responsible Party):
Henrik Malchau, 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 50 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.

Condition or disease Intervention/treatment
Osteoarthritis of the Knee Traumatic Arthritis of the Knee Procedure: Total knee arthroplasty

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-Term Multicenter Evaluation of the E1® Tibial Bearing
Study Start Date : September 2011
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: E1 Tibial bearing
All patients received an E1 polyethylene tibial bearing which is the material being monitored in this study.
Procedure: Total knee arthroplasty
Surgical implantation of total knee components for the treatment of osteoarthritis.

Primary Outcome Measures :
  1. Survivorship, as determined by the implant remaining within the patient. [ Time Frame: 10 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01374230

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Henrik Malchau, MD, PhD Massachusetts General Hospital

Responsible Party: Henrik Malchau, Director of Reseach, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01374230     History of Changes
Other Study ID Numbers: 2010-P-001922
First Posted: June 15, 2011    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by Henrik Malchau, Massachusetts General Hospital:
clinical outcomes
radiographic outcomes
total knee arthroplasty

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases