Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00380549
Status:
COMPLETED
Last Update Posted:
2020-03-10
First Post:
2006-09-23
Brief Title:
A Comparison of an Advanced Metal Hip System to a Resurfacing Hip System
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
Official Title:
A Prospective Case Series Pilot Study Comparing Ion Levels and Clinical Outcomes of the CONSERVE A-Class Type Hip System With BFH Technology to the CONSERVE Plus Total Hip Resurfacing System
Status:
COMPLETED
Status Verified Date:
2020-03
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:
The primary purpose of the current study is to investigate if the CONSERVE A-Class Total Hip with BFH technology will lead to lower blood ion levels in patients as compared to patients in a recent study who received the CONSERVE Plus Total Resurfacing Hip System another metal-on-metal device We are also comparing functional and radiographic x-rays outcomes between patients who receive the CONSERVE A-Class Total Hip compared to those who have received the CONSERVE Plus Total Resurfacing Hip System
Detailed Description:
A standard hip replacement involves replacing your hip joint with several parts the cup which forms the socket in the pelvis a head that forms a new ball for the top of the thigh bone and a stem which is placed into the thigh bone Typically the socket is made out of metal and plastic and the ball and stem are made out of metal
Recently new metal-on-metal hip replacement systems have been developed where both the socket and the shell are made out of metal This can cause metal ions to be released into the body The CONSERVE A-Class Total Hip with BFH technology is a new metal-on-metal total hip system which utilizes a large diameter femoral head 36-54 mm more similar to the size of the original head ie your original bone Further this system utilizes an advanced metal design which wears at a slower rate than typical metal-on-metal implants Therefore the primary purpose of the current study is to investigate if the CONSERVE A-Class Total Hip with BFH technology will lead to lower blood ion levels in patients as compared to patients in a recent study who received the CONSERVE Plus Total Resurfacing Hip System another metal-on-metal device We are also comparing functional and radiographic x-rays outcomes between patients who receive the CONSERVE A-Class Total Hip compared to those who have received the CONSERVE Plus Total Resurfacing Hip System
Recently new metal-on-metal hip replacement systems have been developed where both the socket and the shell are made out of metal This can cause metal ions to be released into the body The CONSERVE A-Class Total Hip with BFH technology is a new metal-on-metal total hip system which utilizes a large diameter femoral head 36-54 mm more similar to the size of the original head ie your original bone Further this system utilizes an advanced metal design which wears at a slower rate than typical metal-on-metal implants Therefore the primary purpose of the current study is to investigate if the CONSERVE A-Class Total Hip with BFH technology will lead to lower blood ion levels in patients as compared to patients in a recent study who received the CONSERVE Plus Total Resurfacing Hip System another metal-on-metal device We are also comparing functional and radiographic x-rays outcomes between patients who receive the CONSERVE A-Class Total Hip compared to those who have received the CONSERVE Plus Total Resurfacing Hip System
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None