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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00527839
Other study ID # 2013-014
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 2007
Est. completion date April 2027

Study information

Verified date October 2023
Source Hospital for Special Surgery, New York
Contact Robert Marx, MD
Phone 212-606-1645
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date April 2027
Est. primary completion date April 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Hospital for Special Surgery New York New York
United States Hospital for Special Surgery New York New York

Sponsors (1)

Lead Sponsor Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

See also
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Terminated NCT03880955 - A Post-Market Clinical Evaluation of the ReUnion Reverse Shoulder Arthroplasty (RSA) System
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