Hospital for Special Surgery Shoulder Arthroplasty Cohort

This study is currently recruiting participants.
Verified February 2013 by Hospital for Special Surgery, New York
Sponsor:
Information provided by (Responsible Party):
Dr. Lisa Mandl, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT00527839
First received: September 7, 2007
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

Total joint replacements are some of the most successful medical devices developed over the last fifty years. They enable millions of people to remain ambulatory and pain free, with minimal risk. In 2002, over 200,000 total hip replacements, 350,000 total knee replacements, and 25,000 total or partial shoulder replacements were performed in the United States (HCUP data). Future use will likely be even higher: it is estimated that by the year 2020, the population 65 and over in developed countries will increase by 71%. Existing studies do not provide adequate prospective data to evaluate long-term outcomes.

HSS is a world leader in total joint replacement including total shoulder arthroplasty. However, there is no systematic follow-up or evaluation of patients who have their shoulders replaced here.

The purpose of this study is to establish a prospective cohort of HSS total shoulder arthroplasty to evaluate predictors of outcome, causes of failure and to allow ongoing evaluation of the results of our patients over time.


Condition
Shoulder Arthroplasty

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Prospective Evaluation of the Clinical and Economic Outcomes of Total Joint Replacement: HSS Shoulder Arthroplasty Cohort

Further study details as provided by Hospital for Special Surgery, New York:

Estimated Enrollment: 250
Study Start Date: April 2007
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (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:   Non-Probability Sample
Study Population

We will be asking all patients undergoing a total shoulder arthroplasty to participate.

Criteria

Inclusion Criteria:

  • 18 years or older and undergoing total shoulder arthroplasty at HSS

Exclusion Criteria:

  • No other exclusion criteria. Pregnant women are eligible for the registry as this is a non-interventional study which only involves filling out questionnaires.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00527839

Contacts
Contact: Robert Marx, MD 212-606-1645
Contact: Kaitlyn Lillemoe, BA 212-606-1866 lillemoek@hss.edu

Locations
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Gina Aharonoff, MS    646-797-8904    aharonoffg@hss.edu   
Contact: Kaitlyn Lillemoe       lillemoek@hss.edu   
Sub-Investigator: Lisa Mandl, MD         
Sub-Investigator: Thomas Sculco, MD         
Principal Investigator: Robert Marx, MD         
Sub-Investigator: Stephen Lyman, PhD         
Sub-Investigator: Alvin Mushlin, MD,ScM         
Sub-Investigator: Hassan Ghomrawi, PhD         
Sub-Investigator: Stephen Incavo, MD         
Sub-Investigator: John Rutledge         
Sub-Investigator: Jason Guardado         
Sub-Investigator: Madhu Mazumdar, PhD         
Sub-Investigator: Stephen Goldring, MD         
Sub-Investigator: Renee Razzano, MA         
Sub-Investigator: Jo Hannafin, MD,PhD         
Sub-Investigator: Gina Aharonoff         
Sub-Investigator: Andrew Weiland, MD         
Sub-Investigator: Answorth A Allen, MD         
Sub-Investigator: David Altchek, MD         
Sub-Investigator: Struan H Coleman, MD, PhD         
Sub-Investigator: Frank Cordasco, MD         
Sub-Investigator: Edward V Craig, MD         
Sub-Investigator: David M Dines, MD         
Sub-Investigator: Stephen Fealy, MD         
Sub-Investigator: Anne Kelly, MD         
Sub-Investigator: Bryan Kelly, MD         
Sub-Investigator: John D MacGillivray, MD         
Sub-Investigator: Michael Maynard, MD         
Sub-Investigator: Stephen J O'Brien, MD         
Sub-Investigator: Andrew D Pearle, MD         
Sub-Investigator: Beth Shubin Stein, MD         
Sub-Investigator: Scott Rodeo, MD         
Sub-Investigator: Howard A Rose, MD         
Sub-Investigator: Russell F Warren, MD         
Sub-Investigator: Thomas L Wickiewicz, MD         
Sub-Investigator: Riley J Williams, MD         
Sub-Investigator: Kenneth Mathis, MD         
Sub-Investigator: Nadia Camille         
Sub-Investigator: Justine Shum         
Sub-Investigator: Tamara Hagoel         
Sub-Investigator: Daniel Fischer         
Sub-Investigator: Kaitlyn Lillemoe         
Sub-Investigator: Nam Giang         
Sub-Investigator: Huong Do, MS         
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Gina Aharonoff    646-797-8904    aharonoffg@hss.edu   
Contact: Kaitlyn Lillemoe       lillemoek@hss.edu   
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Principal Investigator: Robert Marx, MD Hospital for Special Surgery, New York
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Lisa Mandl, Dr. Lisa Mandl, MD, MPH, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT00527839     History of Changes
Other Study ID Numbers: 26117
Study First Received: September 7, 2007
Last Updated: February 11, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 16, 2014