Long-Term Multicenter Evaluation of the E1® Tibial Bearing

This study is currently recruiting participants.
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
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 April 16, 2014