Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454506
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2007-03-29
Brief Title:
Hospital for Special Surgery Hip 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 HSS Hip Arthroplasty Cohort
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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 hip 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 hip arthroplasty
Detailed Description:
None
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