Ultrasound Imaging of Dual Mobility Cup

NCT ID: NCT05177224

Last Updated: 2022-01-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2023-01-31

Brief Summary

The concept of dual mobility cup (DMC), developed in the 1970s by Gilles Bousquet, allows a greater motion and a better stability of the implants, reducing the prosthetic dislocations frequency in at-risk populations. This type of prosthesis has a small-diameter head that ensures a low wear rate and a large-diameter head, with a polyethylene liner, to increase prosthetic stability. This prosthesis has survival rates comparable to those found with conventional prostheses. However, actually, its in vivo behaviour has not yet been established, leading orthopaedic surgeons to keep this concept for patients with a high risk of dislocation (elderly subjects, neurological pathologies, spinal pathologies, falls, etc.). To date, no in vivo studies have been carried out - non-invasively and dynamically - to understand the biomechanical behaviour and the stability properties of the dual mobility cup implanted in patients.

The objective of this study is to visualize and quantify the in vivo movement of the polyethylene liner using 3D ultrasound imaging. The second objective is to obtain in vivo data (using the motion analysis system and the force platform) allowing the use of a musculoskeletal model to improve the understanding of the prosthetic dislocation phenomenon.

Participants will carry out daily life activities (walk, chair up, etc.). During this study, liner ultrasound acquisitions and motion analysis of the lower limb will be performed, thanks to a movement analysis system composed of cameras coupled to a force platform.

Hip kinematics will be obtained from the motion analysis data and will be based on the model of Leardini et al. 2007. The position of the liner and liner plane will be determined using 3D ultrasound data. The abduction and anteversion motion of the liner plane will be measured relative to the pelvic landmark.

Conditions

Dual Mobility Cups

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participants with dual mobility cup

Group Type: EXPERIMENTAL

Ultrasound acquisitions to define liner position during movements

Intervention Type: OTHER

Ultrasound acquisition of the dual mobility cup will be performed before and after movement. Acquisitions will be performed on the groin area.

Movement will be performed 3 times and are:

• Walking
• Knee-bending
• Standing up
• Stair climbing Movement acquisition of the lower limb will be performed using reflective markers placed on the skin. The movements will be recorded using motion capture system (infrared cameras). The load applied by the patients on the ground when doing these movements will be recorded with a force plate.

Interventions

Ultrasound acquisitions to define liner position during movements

Ultrasound acquisition of the dual mobility cup will be performed before and after movement. Acquisitions will be performed on the groin area.

Movement will be performed 3 times and are:

• Walking
• Knee-bending
• Standing up
• Stair climbing Movement acquisition of the lower limb will be performed using reflective markers placed on the skin. The movements will be recorded using motion capture system (infrared cameras). The load applied by the patients on the ground when doing these movements will be recorded with a force plate.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient having signed a free and informed consent
• Being affiliated or benefiting from a social security system
• Having dual mobility cup for at least 1 year
• Outside of a period of exclusion from the national file of persons undergoing biomedical research
• Age greater than or equal to 50 years
• Of a cognitive level compatible with oral communication, the respect of instructions and the understanding of the gestures carried out

Exclusion Criteria

• Persons who are not physically able to perform tests
• Persons currently participating in another research project with an exclusion period
• Persons of full age under legal protection or unable to express their consent
• Pregnant or breast-feeding women (Article L1121-5 of the Public Health Code (CSP))
• Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care and persons admitted to a health or social institution for purposes other than research

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospices Civils de Lyon - Hôpital Lyon Sud - Service de Chirurgie Orthopédique

Lyon, , France

Countries

France

Central Contacts

Michel Henry FESSY, Pr

Role: CONTACT

michel.fessy@chu-lyon.fr

426739668 ext. +33

Louis RIGLET, PhD student

Role: CONTACT

louis.riglet@creatis.insa-lyon.fr

683526953 ext. +33

Facility Contacts

Michel Henri FESSY, Pr

Role: primary

michel.fessy@chu-lyon.fr

426739668 ext. +33

Other Identifiers

69HCL21_0884

Identifier Type: -

Identifier Source: org_study_id