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Hospital for Special Surgery Hip Arthroplasty Cohort

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dr. Lisa Mandl, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT00454506
First received: March 29, 2007
Last updated: September 24, 2012
Last verified: September 2012

March 29, 2007
September 24, 2012
April 2007
April 2017   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00454506 on ClinicalTrials.gov Archive Site
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Hospital for Special Surgery Hip Arthroplasty Cohort
Prospective Evaluation of the Clinical and Economic Outcomes of Total Joint Replacement: HSS Hip Arthroplasty Cohort

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

Hip Arthroplasty
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3000
April 2017
April 2017   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00454506
26131
Yes
Dr. Lisa Mandl, Hospital for Special Surgery, New York
Hospital for Special Surgery, New York
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Thomas P Sculco, MD Hospital for Special Surgery, New York
Hospital for Special Surgery, New York
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP