Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454467
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-19
First Post:
2007-03-29
Brief Title:
Hospital for Special Surgery Knee Arthroplasty Cohort
Sponsor:
Hospital for Special Surgery New York
Organization:
Hospital for Special Surgery New York
Study Overview
Official Title:
Prospective Evaluation of the Clinical and Economic Outcomes of Total Joint Replacement The HSS Knee Arthroplasty Cohort
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 200000 total hip replacements 350000 total knee replacements and 25000 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
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
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 200000 total hip replacements 350000 total knee replacements and 25000 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 2000 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
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 2000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None