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Hospital for Special Surgery Shoulder Arthroplasty Cohort

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ClinicalTrials.gov Identifier: NCT00527839
Recruitment Status : Recruiting
First Posted : September 11, 2007
Last Update Posted : May 25, 2017
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Brief Summary:

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 or disease
Shoulder Arthroplasty

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Prospective Evaluation of the Clinical and Economic Outcomes of Total Joint Replacement: HSS Shoulder Arthroplasty Cohort
Study Start Date : April 2007
Estimated Primary Completion Date : April 2027
Estimated Study Completion Date : April 2027

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We will be asking all patients undergoing a total shoulder arthroplasty to participate.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00527839

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

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
Principal Investigator: Robert Marx, MD Hospital for Special Surgery, New York

Additional Information:
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT00527839     History of Changes
Other Study ID Numbers: 26117
First Posted: September 11, 2007    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017