Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04587440
Status:
UNKNOWN
Last Update Posted:
2022-01-11
First Post:
2020-10-02
Brief Title:
Is the Dynamic of the Pelvic Bone Altered After a Total Hip Replacement
Sponsor:
University Hospital Brest
Organization:
University Hospital Brest
Study Overview
Official Title:
Is the Dynamic of the Pelvic Bone Altered After a Total Hip Replacement
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
RECRUITING
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:
DYPAMAT
Brief Summary:
Total hip replacement is one of the most common surgical procedure in France In 2010 an estimated 147 513 total hip procedures were performed This number is constantly increasing
Although it is common it can lead to many complications The intra-prosthetic luxation is the second one after aseptic loosening
The luxation risk is multifactorial and depends on the relative orientation of femoral et acetabular components This orientation is influenced by statics and dynamics parameters
So far the literature shows that only static parameters are considered by surgeons Thus in reference to Lewinneck publication which states that the luxation risk is lower if the cup is oriented with 15 - 10 of anteversion and 40- 10 of inclination with respect to the anterior pelvic plan APP Defined by the two anterosuperior iliacs spines and pubic symphysis
However this approach is only static and do not take into account the variations of pelvic plan orientation during everyday life
To consider these variations of pelvic inclination it is possible to measure the angle between APP and the horizontal in lying position or the vertical in standing position plan
Several devices allow the measure of pelvic inclination but they all have important limits EOS radiography scanner or navigation A new device has been developed in Brest to measure this inclination in several positions of the daily lifeThis software has already been tested in healthy volunteers and results demonstrate an excellent accuracy and reproducibility
The goal of this study is to described the dynamic of the pelvic bone thanks to this ultrasound based device and to assess the amount of variation induced by hip replacement procedures
Although it is common it can lead to many complications The intra-prosthetic luxation is the second one after aseptic loosening
The luxation risk is multifactorial and depends on the relative orientation of femoral et acetabular components This orientation is influenced by statics and dynamics parameters
So far the literature shows that only static parameters are considered by surgeons Thus in reference to Lewinneck publication which states that the luxation risk is lower if the cup is oriented with 15 - 10 of anteversion and 40- 10 of inclination with respect to the anterior pelvic plan APP Defined by the two anterosuperior iliacs spines and pubic symphysis
However this approach is only static and do not take into account the variations of pelvic plan orientation during everyday life
To consider these variations of pelvic inclination it is possible to measure the angle between APP and the horizontal in lying position or the vertical in standing position plan
Several devices allow the measure of pelvic inclination but they all have important limits EOS radiography scanner or navigation A new device has been developed in Brest to measure this inclination in several positions of the daily lifeThis software has already been tested in healthy volunteers and results demonstrate an excellent accuracy and reproducibility
The goal of this study is to described the dynamic of the pelvic bone thanks to this ultrasound based device and to assess the amount of variation induced by hip replacement procedures
Detailed Description:
None
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