Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT00454467 |
| Other study ID # |
2015-093 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 2007 |
| Est. completion date |
April 2027 |
Study information
| Verified date |
October 2023 |
| Source |
Hospital for Special Surgery, New York |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
