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Long-Term Multicenter Evaluation of the E1® Tibial Bearing

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Henrik Malchau, Massachusetts General Hospital Identifier:
First received: June 14, 2011
Last updated: May 2, 2017
Last verified: May 2017
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 Intervention
Osteoarthritis of the Knee Traumatic Arthritis of the Knee Procedure: Total knee arthroplasty

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-Term Multicenter Evaluation of the E1® Tibial Bearing

Resource links provided by NLM:

Further study details as provided by Henrik Malchau, Massachusetts General Hospital:

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

Estimated Enrollment: 50
Study Start Date: September 2011
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Henrik Malchau, Director of Reseach, Massachusetts General Hospital Identifier: NCT01374230     History of Changes
Other Study ID Numbers: 2010-P-001922
Study First Received: June 14, 2011
Last Updated: May 2, 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 processed this record on August 18, 2017