Prospective Evaluation of the Clinical and Economic Outcomes of Total Joint Replacement: The HSS Shoulder 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

Robert Marx MD, MSc

Co-Investigators

Lisa Mandl, MD, MPH  
Stephen Lyman, PhD  
Alvin Mushlin, MD, ScM  
Jonathan Kassak  
Carolyn Thai   
Whitney Johnson   
Madhu Mazumdar, PhD  
Stephen Goldring MD  
Renee Razanno  
Laura Robbins DSW  
Jo Hannafin MD PhD   
Andrew Weiland, MD  
Answorth A. Allen, MD
David W. Altchek, MD
Struan H. Coleman, MD, PhD
Frank A. Cordasco, MD
Edward V. Craig, MD
David M. Dines, MD
Stephen Fealy MD
Anne Kelly, MD
Bryan Kelly, MD
John D. MacGillivray, MD
Michael J. Maynard, MD
Stephen J. O'Brien, MD
Andrew D. Pearle, MD
Beth Shubin Stein MD
Scott A. Rodeo, MD
Howard A. Rose, MD
Russell F. Warren, MD
Thomas L. Wickiewicz, MD
Riley J. Williams, MD
Lisa Vasanth, MD
Susan Bloomberg 
Lisa Bowerman 
John Rutledge
Jessica Ryu
Rhonda El-Sheikh
Nicole Felder
Elizabeth Cody 
Jason Guardado
Kenneth Mathis, MD
Nadia Camille

Summary

We will enroll all TSA patients who undergo surgery at HSS and consent to be in the study.  We estimate this to be approximately 200 patients a year.  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 shoulder arthroplasty at HSS

Contact Information

Principal Investigator
Robert Marx MD, MSc
212.606.1645

Research Coordinator
Samuel Chu
212.606.1866