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Hospital for Special Surgery Shoulder Arthroplasty Cohort

Sponsor
Hospital for Special Surgery, New York (Other)
Overall Status
Recruiting
CT.gov ID
NCT00527839
Collaborator
(none)
250
Enrollment
2
Locations
240
Duration (Months)
125
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Apr 1, 2007
    Anticipated Primary Completion Date :
    Apr 1, 2027
    Anticipated Study Completion Date :
    Apr 1, 2027

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      Site City State Country Postal Code
      1 Hospital for Special Surgery New York New York United States 10021
      2 Hospital for Special Surgery New York New York United States 10021

      Sponsors and Collaborators

      • Hospital for Special Surgery, New York

      Investigators

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

      Study Documents (Full-Text)

      None provided.

      More Information

      Additional Information:

      Publications

      None provided.
      Responsible Party:
      Hospital for Special Surgery, New York
      ClinicalTrials.gov Identifier:
      NCT00527839
      Other Study ID Numbers:
      • 2013-014
      First Posted:
      Sep 11, 2007
      Last Update Posted:
      Oct 5, 2021
      Last Verified:
      Oct 1, 2021

      Study Results

      No Results Posted as of Oct 5, 2021