DePuy Revision TKA Implant 5yr Survivorship

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. Identifier: NCT01245478
Recruitment Status : Withdrawn (Retrospective record review only (no subject enrollment). Contract never executed between Sponsor and Site.)
First Posted : November 22, 2010
Last Update Posted : May 1, 2013
Depuy, Inc.
Information provided by (Responsible Party):
The New England Baptist Hospital

Brief Summary:

This will be a retrospective chart review of 200 charts of adult patients who have undergone a revision TKA at New England Baptist Hospital and who received implant component(s) manufactured by DePuy Orthopedics. The data will be collected retrospectively after patients are seen clinically for a minimum of five years after surgery to answer:

  1. What is the five-year survivorship of revision a knee prosthesis containing components manufactured by DePuy Orthopedics among adult revision TKA patients?
  2. What patient factors are associated with the need for re-operation after revision TKA among patients receiving DePuy implant components? How do clinical outcomes change from baseline over the five-year follow-up after revision TKA surgery?

Data collection will include patient-reported and clinician-reported measures.

Condition or disease
Complications; Arthroplasty, Mechanical

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Clinical Outcome and 5-year Implant Survival Rate Among Adult Revision Total Knee Arthroplasty Patients With DePuy Implant Components
Study Start Date : November 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Any NEBH patients who received DePuy implant components during a Revision TKA procedure, performed by either:

  • Dr. Geoffrey Van Flandern
  • Dr. David Mattingly
  • Dr. James Nairus
  • Dr. James Bono
  • Dr. Daniel Ward
  • Dr. Carl Talmo

Inclusion Criteria:

  • Received a Revision TKA (must have been initial revision)

    --Received J&J/DePuy implant components for initial revision

  • Procedure performed at New England Baptist Hospital

Exclusion Criteria:

  • 2nd Revision TKA on knee
  • Received femoral or tibial components not of DePuy manufacture

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 identifier (NCT number): NCT01245478

Sponsors and Collaborators
The New England Baptist Hospital
Depuy, Inc.
Principal Investigator: John Richmond, MD New England Baptist Hospital

Responsible Party: The New England Baptist Hospital Identifier: NCT01245478     History of Changes
Other Study ID Numbers: IIS-000105
First Posted: November 22, 2010    Key Record Dates
Last Update Posted: May 1, 2013
Last Verified: April 2013

Keywords provided by The New England Baptist Hospital:
Surgical Procedures, Elective