Hospital for Special Surgery Knee Arthroplasty Cohort

StatusActive, Not Recruiting
PhaseNot specified
Started

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Record History

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  1. 8 versions Re-verified since May 24, 2018, no change to tracked fieldsv14-v21
  2. Notable Primary and study completion dates: Apr 2017 to Apr 2027v13
  3. 2 versions Re-verified since Aug 17, 2015, no change to tracked fieldsv11-v12
  4. Notable Primary completion date: Apr 2012 to Apr 2017
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 2 to 1
    v10
  5. Re-verified, no change to tracked fieldsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Minor Site contacts updated at 1 of 2 sitesv8
  2. Minor Site contacts updated at 1 of 2 sitesv7
  3. Minor Site contacts updated at 1 of 2 sitesv6
  4. Notable Enrollment target: 2000 to 3000
    • Study sites: 1 to 2
    v5
  5. Minor Study title shortened, about 1 wordv4
  6. Minor Primary completion date: Apr 2012
    • Study completion date: Apr 2017
    • Interventions: Cost Data will be collected via hospital billing databases. (Procedure), In-hospital post-operative data will be collected (Procedure)… to Baseline Questionnaire (Procedure), Cost Data (Procedure), Follow-up questionnaires (Procedure), In-hospital post-operative data will be…
    v3
  7. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Enrollment target: 2000
    • Start date: Apr 2007
    • Eligibility criteria expanded, about 17 words
    • Study description expanded, about 475 words
    • Site details revised
    • Study title shortened, about 9 words
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 knee arthroplasty.
Trial Details
NCT Number NCT00454467
Lead Sponsor Hospital for Special Surgery, New York
Collaborators: Agency for Healthcare Research and Quality (AHRQ)
Conditions
(from sponsor)
Knee Arthroplasty
Enrollment 3,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov