Is the Dynamic of the Pelvic Bone Altered After a Total Hip Replacement ?

Coxarthrosis; Primary Clinical Trial

— DYPAMAT  

Official title:

Is the Dynamic of the Pelvic Bone Altered After a Total Hip Replacement ?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04587440
• Other study ID #: 29BRC20.0120
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2021
• Est. completion date: August 2, 2023

Study information

• Verified date: January 2022
• Source: University Hospital, Brest
• Contact: Eric Stindel, PUPH
• Phone: +33298347275
• Email: eric.stindel[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 53
• Est. completion date: August 2, 2023
• Est. primary completion date: February 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coxarthrosis; Primary
• Coxarthrosis; Secondary
• Osteoarthritis, Hip

Intervention

Other:
• Pelvic inclination measurement
Ultra-sound based measurements of the pelvic inclination lying, standing and seating position. EOX X-ray in seating position.

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of the pelvic incidence	The main evaluation criterion is the variation of the pelvic incidence between pre- and post-operative total hip replacements	Day 0 - Month 3
Secondary	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.	Day 0 - Month 3
Secondary	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.	Day 0 - Month 3
Secondary	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.	Day 0 - Month 3
Secondary	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.	Day 0 - Month 3