DePuy Revision TKA Implant 5yr Survivorship

NCT ID: NCT01245478

Last Updated: 2013-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Complications; Arthroplasty, Mechanical

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Depuy, Inc.

INDUSTRY

Sponsor Role collaborator

The New England Baptist Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John Richmond, MD

Role: PRINCIPAL_INVESTIGATOR

New England Baptist Hospital

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IIS-000105

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Computer Assisted Total Knee Replacement
NCT00279838 COMPLETED PHASE4
Cemented vs. Cementless TKA
NCT04597684 TERMINATED NA
Knee Arthroplasty Registry
NCT01132365 UNKNOWN