Dual Mobility CupsUSDMCNCT05177224
Ultrasound Imaging of Dual Mobility Cup
A study testing Ultrasound acquisitions to define liner position during movements in people with Dual Mobility Cups, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dual Mobility Cups
- What is being tested?
- Ultrasound acquisitions to define liner position during movements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2022to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon - Hôpital Lyon Sud - Service de Chirurgie Orthopédique
Lyon, 69310
Michel Henri FESSY, Pr, 426739668 ext. +33, michel.fessy@chu-lyon.fr
About this study
Official title: In Vivo Study of the Dual Mobility Cup Stability and Mobility Using Ultrasound Imaging
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.
Read more
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
- Being tested
- Ultrasound acquisitions to define liner position during movements
- Keywords
- dual mobility cup, liner, motion analysis, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound acquisitions to define liner position during movementsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with dual mobility cup | Experimental | Not described Receives: Other: Ultrasound acquisitions to define liner position during movements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liner position using ultrasound
The liner position and liner plane are defined using 3D ultrasound data. Abduction and anteversion motion of the liner plane are measured relative to the pelvic landmark.
Measured: At inclusion (At least one year after surgery)
Secondary outcomes (2)
Hip kinematics using motion analysis
Hip kinematics is obtained using motion analysis data and based on the Leardini et al. model (Leardini et al. 2007). The pelvic benchmark will be determined according to the ISB recommendations (Derrick et al. 2020).
Measured: At inclusion (At least one year after surgery)
Forces and moments during movements
Forces and moments during movement are measured using a force plate.
Measured: At inclusion (At least one year after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study startJan 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dual Mobility CupsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177224
- Sponsor's protocol ID
- 69HCL21_0884
- Acronym
- USDMC
- Status last verified
- Dec 2021
- First submitted
- 15 Dec 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Study of the Dual Mobility Cup Stability and Mobility Using Ultrasound Imaging
- ClinicalTrials.gov ID
- NCT05177224
- Acronym / sponsor ID
- USDMC / 69HCL21_0884
- Conditions
- Dual Mobility Cups
- Keywords
- dual mobility cup, liner, motion analysis, ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with dual mobility cup | Experimental | Other: Ultrasound acquisitions to define liner position during movements |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound acquisitions to define liner position during movementsUltrasound 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. | Other | Participants with dual mobility cup |
Primary outcome
Liner position using ultrasound
Time frame: At inclusion (At least one year after surgery)
The liner position and liner plane are defined using 3D ultrasound data. Abduction and anteversion motion of the liner plane are measured relative to the pelvic landmark.
2 secondary outcomes
Hip kinematics using motion analysis
Time frame: At inclusion (At least one year after surgery)
Forces and moments during movements
Time frame: At inclusion (At least one year after surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Dual Mobility Cups
RecruitingObservational study
Multicenter Mpact DM France
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RecruitingPhase 4
E-Type - Early Wear of Polyethylene Liners Used in DMC
Osteoarthritis, Osteonecrosis
Active, not recruitingObservational study
Bone Fixation of Mpact Double Mobility Cup
Total Hip Replacement
Recruiting
Comparison of Wear Between Two Dual-mobility Acetabular Cups in Patients Undergoing Total Hip Arthroplasty
Hip Arthroplasty Replacement
Recruiting
Comparing Dual-mobility Cups Versus Unipolar Cups for Unselected Primary Total Hip Arthroplasty by Direct Anterior Approach
Primary Total Hip Arthroplasty, Primary Total Hip Replacement
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound acquisitions to define liner position during movements in people with Dual Mobility Cups, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel Henry FESSY, Pr (426739668 ext. +33, michel.fessy@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liner position using ultrasound (time frame: At inclusion (At least one year after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.