Coxarthrosis; PrimaryDYPAMATNCT04587440
Is the Dynamic of the Pelvic Bone Altered After a Total Hip Replacement ?
A study testing Pelvic inclination measurement in people with Coxarthrosis; Primary and Coxarthrosis; Secondary, run by University Hospital, Brest at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coxarthrosis; Primary, Coxarthrosis; Secondary
- What is being tested?
- Pelvic inclination measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2021to 26 Feb 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Coxarthrosis; Primary, Coxarthrosis; Secondary
- Being tested
- Pelvic inclination measurement
- Medical subject headings
- Osteoarthritis, Hip, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic inclination measurementOther
Ultra-sound based measurements of the pelvic inclination lying, standing and seating position. EOX X-ray in seating position.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Experimental | 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 Receives: Other: Pelvic inclination measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of the pelvic incidence
The main evaluation criterion is the variation of the pelvic incidence between pre- and post-operative total hip replacements
Measured: Day 0 - Month 3
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0 - Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start2 Feb 2021
- Primary completion26 Feb 2022
- Study completion26 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coxarthrosis; PrimaryStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587440
- Sponsor's protocol ID
- 29BRC20.0120
- Acronym
- DYPAMAT
- Status last verified
- Jun 2026
- First submitted
- 2 Oct 2020
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Dynamic of the Pelvic Bone Altered After a Total Hip Replacement ?
- ClinicalTrials.gov ID
- NCT04587440
- Acronym / sponsor ID
- DYPAMAT / 29BRC20.0120
- Conditions
- Coxarthrosis; Primary, Coxarthrosis; Secondary
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 26 Feb 2022 (actual)
- Study completion
- 26 Feb 2022 (actual)
- First posted
- 14 Oct 2020 (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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study of the variation of the dynamic of the pelvic bone in pre and post operative of a hip replacement
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Other: Pelvic inclination measurementAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Pelvic inclination measurementUltra-sound based measurements of the pelvic inclination lying, standing and seating position. EOX X-ray in seating position. | Other | Patient |
Primary outcome
Variation of the pelvic incidence
Time frame: Day 0 - Month 3
The main evaluation criterion is the variation of the pelvic incidence between pre- and post-operative total hip replacements
4 secondary outcomes
Analysis of the correlation between the variation in pelvic incidence while sitting, standing and lying down and the implant settings
Time frame: 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)
Time frame: Day 0 - Month 3
Analysis of the correlation between variation in pelvic incidence while sitting, standing and lying down and clinical parameters (EVA)
Time frame: 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)
Time frame: Day 0 - Month 3
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic inclination measurement in people with Coxarthrosis; Primary and Coxarthrosis; Secondary, run by University Hospital, Brest 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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 8 Jun 2026. 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of the pelvic incidence (time frame: Day 0 - Month 3). 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 8 Jun 2026.