NCT01245478

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. 1.What is the five-year survivorship of revision a knee prosthesis containing components manufactured by DePuy Orthopedics among adult revision TKA patients?
  2. 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?

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2010

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

May 1, 2013

Status Verified

April 1, 2013

Enrollment Period

1.7 years

First QC Date

November 19, 2010

Last Update Submit

April 30, 2013

Conditions

Complications; Arthroplasty, Mechanical

Keywords

Surgical Procedures, Elective

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • John Richmond, MD

    New England Baptist Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2010

First Posted

November 22, 2010

Study Start

November 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

May 1, 2013

Record last verified: 2013-04