Long-Term Multicenter Evaluation of the E1® Tibial Bearing

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Henrik Malchau, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01374230
First received: June 14, 2011
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Survivorship, as determined by the implant remaining within the patient. [ Time Frame: 10 years ] [ Designated as safety issue: No ]

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)
Intervention Details:
    Procedure: Total knee arthroplasty
    Surgical implantation of total knee components for the treatment of osteoarthritis.
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 MGH 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 ClinicalTrials.gov identifier: NCT01374230

Contacts
Contact: Henrik Malchau, Md, PhD 617-726-3866 hmalchau@partners.org
Contact: Charles Bragdon, PhD 617-724-7544 cbragdon@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Henrik Malchau, MD, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Henrik Malchau, Director of Reseach, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01374230     History of Changes
Other Study ID Numbers: 2010-P-001922
Study First Received: June 14, 2011
Last Updated: August 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
clinical outcomes
radiographic outcomes
total knee arthroplasty
survivorship

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

ClinicalTrials.gov processed this record on August 26, 2014