Prospective Evaluation of the Clinical and Economic Outcomes of Total Joint Replacement: The HSS Knee Arthroplasty Cohort

Institutional Review Board, Hospital for Special Surgery

October 05, 2007

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

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Principal Investigator

Thomas P. Sculco, MD

Co-Investigators

Mark Callahan, MD
Stephen Goldring, MD
Whitney Johnson, BA
Jonathan Kassak, BS, MBA
Stephen Lyman, PhD
Lisa Mandl, MD, MPH 
Robert G. Marx, MD, MSc
Madhu Mazumdar, PhD
Alvin Mushlin, MD, ScM 
Renee Razzano, MA  
Laura Robbins, MSW 
Carolyn Thai, BA  
Geoffrey H. Westrich, MD
Friedrich Boettner, MD
Mark P. Figgie, MD
Mathias P. Bostrom, MD
Michael M. Alexiades, MD
Phillip D. Wilson Jr., MD
Douglas E. Padgett, MD
Russell E. Windsor, MD
Alejandro Gonzalez Della Valle, MD
Steven B. Haas, MD
David J. Mayman, MD
Michael J. Maynard, MD
Frank A. Cordasco, MD
Howard A. Rose, MD
Russell F.Warren, MD
Answorth A. Allen, MD
Stephen Fealy, MD
John D. MacGillivray, MD
Thomas L. Wickiewicz MD
Charles N. Cornell, MD
Edward V. Craig, MD
Andrew D. Pearle, MD
Riley J. Williams, MD
Rhonda El-Sheikh
Nicole Felder
Lisa Bowerman
Susan Bloomberg
Jason Guardado
Jessica Ryu
Elizabeth Cody
John Rutledge
Kenneth Mathis, MD
Nadia Camille

Summary

We will enroll all TKA patients who undergo surgery at HSS and consent to be in the study.  We estimate this to be approximately 2600 patients a year, based on 2006 data.  (2575 TKA were performed at HSS in 2006). Patients will receive follow-up questionnaires at one year, two years, and five years after their surgery.

Inclusion/Exclusion Criteria

Patients 18 years or older undergoing total knee arthroplasty at HSS

Contact Information

Principal Investigator
Thomas Sculco, MD
212.606.2478

Research Coordinator
Carolyn Thai
212.774.2754