Is the Dynamic of the Pelvic Bone Altered After a Total Hip Replacement ? (DYPAMAT)
Primary Purpose
Coxarthrosis; Primary, Coxarthrosis; Secondary
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pelvic inclination measurement
Sponsored by
About this trial
This is an interventional other trial for Coxarthrosis; Primary
Eligibility Criteria
Inclusion criteria :
- Patient with primary or secondary hip arthritis, at stage II to III of the radiological classification of Tönnis and for whom total hip replacement is indicated by surgeon.
- Signed consent
- Patient beneficiary of a social security plan
Exclusion Criteria:
- Patient Under 18
- Patient Under protective measure (guardianship, curatorship) or unable to consent
- Patient requiring revision THR
- Patient with geographic mobility plan before the end of the follow-up
- Symptomatic contralateral hip
- Symptomatic dorsolumbar rachis
- Pelvis or spine surgery planed during the follow-up
- Pregnant or nursing woman
Sites / Locations
- CHRU de BrestRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient
Arm Description
All patients will have a clinical examination before surgery and another 3 months after surgery, each including : A medical examination 3 pelvic inclination measurements (1 sitting, 1 lying and 1 standing). These measurements will be done by ultrasound devices. 2 EOS X-rays (1 standing and 1 sitting) of the lower limbs and spine Harris hip score Pain quantification thanks to an EVA scale hand-ground distance
Outcomes
Primary Outcome Measures
Variation of the pelvic incidence
The main evaluation criterion is the variation of the pelvic incidence between pre- and post-operative total hip replacements
Secondary Outcome Measures
Analysis of the correlation between the variation in pelvic incidence while sitting, standing and lying down and the implant settings
Assessed by EOS X-Ray.
Analysis of the correlation between variation in pelvic incidence while sitting, standing and lying down and clinical parameters (Harris hip score)
Clinical examination (Harris hip score) will be performed at day 0 and month 3.
Analysis of the correlation between variation in pelvic incidence while sitting, standing and lying down and clinical parameters (EVA)
Clinical examination (EVA) will be performed at day 0 and month 3.
Analysis of the correlation between variation in pelvic incidence while sitting, standing and lying down and clinical parameters (Hand-ground distance)
Clinical examination (Hand-ground distance) will be performed at day 0 and month 3.
Full Information
NCT ID
NCT04587440
First Posted
October 2, 2020
Last Updated
January 10, 2022
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT04587440
Brief Title
Is the Dynamic of the Pelvic Bone Altered After a Total Hip Replacement ?
Acronym
DYPAMAT
Official Title
Is the Dynamic of the Pelvic Bone Altered After a Total Hip Replacement ?
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2021 (Actual)
Primary Completion Date
February 2, 2023 (Anticipated)
Study Completion Date
August 2, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 life.This 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coxarthrosis; Primary, Coxarthrosis; Secondary
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Study of the variation of the dynamic of the pelvic bone in pre and post operative of a hip replacement
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient
Arm Type
Experimental
Arm Description
All patients will have a clinical examination before surgery and another 3 months after surgery, each including :
A medical examination
3 pelvic inclination measurements (1 sitting, 1 lying and 1 standing). These measurements will be done by ultrasound devices.
2 EOS X-rays (1 standing and 1 sitting) of the lower limbs and spine
Harris hip score
Pain quantification thanks to an EVA scale
hand-ground distance
Intervention Type
Other
Intervention Name(s)
Pelvic inclination measurement
Intervention Description
Ultra-sound based measurements of the pelvic inclination lying, standing and seating position. EOX X-ray in seating position.
Primary Outcome Measure Information:
Title
Variation of the pelvic incidence
Description
The main evaluation criterion is the variation of the pelvic incidence between pre- and post-operative total hip replacements
Time Frame
Day 0 - Month 3
Secondary Outcome Measure Information:
Title
Analysis of the correlation between the variation in pelvic incidence while sitting, standing and lying down and the implant settings
Description
Assessed by EOS X-Ray.
Time Frame
Day 0 - Month 3
Title
Analysis of the correlation between variation in pelvic incidence while sitting, standing and lying down and clinical parameters (Harris hip score)
Description
Clinical examination (Harris hip score) will be performed at day 0 and month 3.
Time Frame
Day 0 - Month 3
Title
Analysis of the correlation between variation in pelvic incidence while sitting, standing and lying down and clinical parameters (EVA)
Description
Clinical examination (EVA) will be performed at day 0 and month 3.
Time Frame
Day 0 - Month 3
Title
Analysis of the correlation between variation in pelvic incidence while sitting, standing and lying down and clinical parameters (Hand-ground distance)
Description
Clinical examination (Hand-ground distance) will be performed at day 0 and month 3.
Time Frame
Day 0 - Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria :
Patient with primary or secondary hip arthritis, at stage II to III of the radiological classification of Tönnis and for whom total hip replacement is indicated by surgeon.
Signed consent
Patient beneficiary of a social security plan
Exclusion Criteria:
Patient Under 18
Patient Under protective measure (guardianship, curatorship) or unable to consent
Patient requiring revision THR
Patient with geographic mobility plan before the end of the follow-up
Symptomatic contralateral hip
Symptomatic dorsolumbar rachis
Pelvis or spine surgery planed during the follow-up
Pregnant or nursing woman
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Stindel, PUPH
Phone
+33298347275
Email
eric.stindel@chu-brest.fr
Facility Information:
Facility Name
CHRU de Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric STINDEL, Pr
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data that underlie results in a publication.
IPD Sharing Time Frame
Data will be available beginning three years and ending fifteen years following the final study report completion.
IPD Sharing Access Criteria
Data access request will be reviewed by the internal committee of Brest University Hospital. Requestor will be required to sign and complete a data access agreement.
Learn more about this trial
Is the Dynamic of the Pelvic Bone Altered After a Total Hip Replacement ?
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