Hospital for Special Surgery Knee 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:
NCT00454467
First received: March 29, 2007
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Knee Arthroplasty
Procedure: Baseline Questionnaire
Procedure: Operative Data
Procedure: Intra-operative data will be collected post-operatively
Procedure: In-hospital post-operative data will be collected
Procedure: Satisfaction data will be extracted from Press/Ganey and on follow-up questionnaires
Procedure: Cost Data
Procedure: Follow-up questionnaires

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of the Clinical and Economic Outcomes of Total Joint Replacement: The HSS Knee Arthroplasty Cohort

Resource links provided by NLM:


Further study details as provided by Hospital for Special Surgery, New York:

Estimated Enrollment: 3000
Study Start Date: April 2007
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    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: Follow-up questionnaires
    Participants will be mailed follow-up questionnaires.
Detailed Description:

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.

The creation of large prospective joint arthroplasty cohorts responds directly to initiatives proposed in the NIH Consensus Development Conferences on Total Knee Replacement. This study will allow in depth analysis from the "Provider and Health Care System Perspective", (one of the important research perspectives advocated by the NIH), including surgeon, surgical technique, type of prosthesis, implantation technique and perioperative care. We will be able to evaluate all patients who receive arthroplasty surgery at HSS, as opposed to a convenience sample, and we will be able to follow patients for the life of their joint replacement. We will also be able to asses patient-level factors affecting outcomes, including medical and socio-demographic characteristics, participation in rehabilitation services, the extent of social support, and the level of patients' physical activity.

The consensus conference emphasized the importance of evaluating the use of TJA in younger patients, as these patients are underrepresented in most existing studies. For example, in one of the most rigorous existing studies of TKA, patients were followed for two years after surgery. However, three centers were needed to recruit 860 TKA patients, whose mean age was 70. By contrast, HSS alone performed over 2,000 total knee replacement surgeries in 2004, of which 41% were in patients under 65 years of age, and 28% were in patients under 60 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00454467

Locations
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Principal Investigator: Thomas Sculco, MD Hospital for Special Surgery, New York
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Lisa Mandl, MD MPH, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT00454467     History of Changes
Other Study ID Numbers: 26132
Study First Received: March 29, 2007
Last Updated: September 24, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 17, 2014