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DePuy Revision TKA Implant 5yr Survivorship

This study has been withdrawn prior to enrollment.
(Retrospective record review only (no subject enrollment). Contract never executed between Sponsor and Site.)
Sponsor:
Collaborator:
Depuy, Inc.
Information provided by (Responsible Party):
The New England Baptist Hospital
ClinicalTrials.gov Identifier:
NCT01245478
First received: November 19, 2010
Last updated: April 30, 2013
Last verified: April 2013
History of Changes

November 19, 2010
April 30, 2013
November 2010
July 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01245478 on ClinicalTrials.gov Archive Site
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DePuy Revision TKA Implant 5yr Survivorship
Clinical Outcome and 5-year Implant Survival Rate Among Adult Revision Total Knee Arthroplasty Patients With DePuy Implant Components

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.
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Observational
Observational Model: Case-Only
Time Perspective: Retrospective
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Probability Sample

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
Complications; Arthroplasty, Mechanical
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01245478
IIS-000105
No
The New England Baptist Hospital
The New England Baptist Hospital
Depuy, Inc.
Principal Investigator: John Richmond, MD New England Baptist Hospital
The New England Baptist Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP