Hospital for Special Surgery Knee Arthroplasty Cohort
NCT00454467 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000
Last updated 2026-02-13
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 knee arthroplasty.
Conditions
- Knee Arthroplasty
Interventions
- PROCEDURE
-
Follow-up questionnaires
Participants will be mailed follow-up questionnaires.
- PROCEDURE
-
Satisfaction data will be extracted from Press/Ganey and on follow-up questionnaires
Follow-up questionnaires will be mailed to participants.
- PROCEDURE
-
Cost Data
Cost Data will be collected via hospital billing databases.
- PROCEDURE
-
Baseline Questionnaire
Patients will fill out a baseline questionnaire prior to surgery.
- PROCEDURE
-
Operative Data
Type of prosthesis and other operative data will be uploaded into our database.
- PROCEDURE
-
Intra-operative data will be collected post-operatively
Research assistants will post-operatively collect data from patient charts.
- PROCEDURE
-
In-hospital post-operative data will be collected
Research assistants will collect information about hospital stay from patient charts.
Sponsors & Collaborators
-
Agency for Healthcare Research and Quality (AHRQ)
collaborator FED -
Hospital for Special Surgery, New York
lead OTHER
Principal Investigators
-
Thomas Sculco, MD · Hospital for Special Surgery, New York
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-04-30
- Primary Completion
- 2027-04-30
- Completion
- 2027-04-30
Countries
- United States
Study Locations
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