Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116948
Status:
COMPLETED
Last Update Posted:
2014-12-05
First Post:
2005-06-30
Brief Title:
A Comparison of Two Total Hip Replacements Hip Resurfacing System Versus Mallory-HeadExeter
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
A Comparison of Two Total Hip Replacements Hip Resurfacing System Versus Mallory-HeadExeter
Status:
COMPLETED
Status Verified Date:
2014-12
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 purpose of this study is to compare two total hip replacement systems Hip Resurfacing System ReCap versus Mallory-HeadExeter
Detailed Description:
In Denmark approximately 7000 primary hip replacements are implanted yearly and the incidence is rising with the increasingly aging population For older patients the incidence of later revisions of hip implantation is low Unfortunately this is not true for younger patients Approximately 20 of patients under 55 years of age at the time of surgery must have the hip implant renewed within 10 years
This is primarily because of the wear generated by polyethylene debris The polyethylene is associated with osteolysis in the proximity of the prosthesis leading to failure of the prosthesis
This unsatisfactory result has led to the development of an alternative hip prosthesis especially to benefit younger and physically active people The new prosthesis should produce less inflammatory debris and less osteolysis induced failure
To avoid the polyethylene particles a new type of prosthesis has been made articulating metal on metal The Hip Resurfacing System consists of an alloy of chrome - cobalt - molybdenum Another point of interest for this prosthesis is also the size of the articulating surfaces which are bigger than usual This will theoretically participate in the generation of metal ions
Study objectives
This randomised prospective study will investigate the emission of Co- Cr- and Mb-ions from Hip Resurfacing System and Mallory-HeadExeter implants respectively The emission is measured as the ion concentration in the urine and is correlated to the inflammatory response in fasting plasma before and after the operation
To assess the walking pattern postoperatively using a 3D gait analysis Vicon Polygon
To assess the postoperative recovery using the Harris hip score and visual analogue scale
The migration of acetabular components will be evaluated by RSA performing radiostereometric analyses at the Orthopaedic Center Aarhus University Hospital The follow-up RSA will be scheduled for week 1 as well as 3 months 12 months 24 months and 5 years after surgery Bone mineral density around the implanted femoral component will be examined by DEXA scan at week 1 as well as 1 year and 2 years after surgery
This is primarily because of the wear generated by polyethylene debris The polyethylene is associated with osteolysis in the proximity of the prosthesis leading to failure of the prosthesis
This unsatisfactory result has led to the development of an alternative hip prosthesis especially to benefit younger and physically active people The new prosthesis should produce less inflammatory debris and less osteolysis induced failure
To avoid the polyethylene particles a new type of prosthesis has been made articulating metal on metal The Hip Resurfacing System consists of an alloy of chrome - cobalt - molybdenum Another point of interest for this prosthesis is also the size of the articulating surfaces which are bigger than usual This will theoretically participate in the generation of metal ions
Study objectives
This randomised prospective study will investigate the emission of Co- Cr- and Mb-ions from Hip Resurfacing System and Mallory-HeadExeter implants respectively The emission is measured as the ion concentration in the urine and is correlated to the inflammatory response in fasting plasma before and after the operation
To assess the walking pattern postoperatively using a 3D gait analysis Vicon Polygon
To assess the postoperative recovery using the Harris hip score and visual analogue scale
The migration of acetabular components will be evaluated by RSA performing radiostereometric analyses at the Orthopaedic Center Aarhus University Hospital The follow-up RSA will be scheduled for week 1 as well as 3 months 12 months 24 months and 5 years after surgery Bone mineral density around the implanted femoral component will be examined by DEXA scan at week 1 as well as 1 year and 2 years after surgery
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