Hospital for Special Surgery Knee Arthroplasty Cohort

NCT00454467 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2026-02-13

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00454467 on ClinicalTrials.gov