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Clinical Trials/NCT00454506
NCT00454506
Active, Not Recruiting
N/A

Prospective Evaluation of the Clinical and Economic Outcomes of Total Joint Replacement: HSS Hip Arthroplasty Cohort

Hospital for Special Surgery, New York2 sites in 1 country3,000 target enrollmentApril 1, 2007

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hip Arthroplasty
Sponsor
Hospital for Special Surgery, New York
Enrollment
3000
Locations
2
Status
Active, Not Recruiting
Last Updated
4 days ago

Overview

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. Most health related quality of life studies in THA and TKA only report data up to twelve months post-operatively. In addition, most large studies of TKA and THA have been performed in Medicare patients. While these databases are important in providing population based data, Medicare studies do not permit any direct patient contact, and provide no information on patients under 65.

Existing studies have also investigated predictors of patient outcome at one and two years after joint arthroplasty. However, very little is known about predictors of prosthesis failure, and there are no validated clinical indicators for choosing one prosthesis model over another. Once a device is FDA approved, there is very little motivation on the part of the developer to perform complete post-marketing research, despite the importance of these data to the public health. Most existent studies are not powered to compare differences between models.

The purpose of this study is to establish a prospective cohort of HSS total hip arthroplasty.

Registry
clinicaltrials.gov
Start Date
April 1, 2007
End Date
April 1, 2027
Last Updated
4 days ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hospital for Special Surgery, New York
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 18 years or older
  • Undergoing total knee arthroplasty at HSS
  • Pregnant women are eligible for the registry as this is a non-interventional study which only involves filling out questionnaires.

Exclusion Criteria

  • No other exclusion criteria;this is a non-interventional study which only involves filling out questionnaires.

Outcomes

Primary Outcomes

Not specified

Study Sites (2)

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