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

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.

Study Overview

• Status: Recruiting
• Conditions: Coxarthrosis; Primary; Coxarthrosis; Secondary
• Intervention / Treatment: Other: Pelvic inclination measurement

• Study Type: Interventional
• Enrollment (Anticipated): 53
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric Stindel, PUPH; Phone Number: +33298347275; Email: eric.stindel@chu-brest.fr

Study Locations

• France
  • Brest, France, 29200
    • Recruiting
    • CHRU de Brest
    • Contact: Eric STINDEL, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Patient; 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 2, 2021
• Primary Completion (ANTICIPATED): February 2, 2023
• Study Completion (ANTICIPATED): August 2, 2023

Study Registration Dates

• First Submitted: October 2, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (ACTUAL): October 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: 29BRC20.0120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No