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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This study has been withdrawn prior to enrollment.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
  Purpose

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
Complications; Arthroplasty, Mechanical

Study Type: Observational
Study Design: 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

Further study details as provided by The New England Baptist Hospital:

Enrollment: 0
Study Start Date: November 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Criteria

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
  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: NCT01245478

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

No publications provided

Responsible Party: The New England Baptist Hospital
ClinicalTrials.gov Identifier: NCT01245478     History of Changes
Other Study ID Numbers: IIS-000105
Study First Received: November 19, 2010
Last Updated: April 30, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014