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This study has been withdrawn prior to enrollment.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
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 April 14, 2014