Arthroplasty, Replacement, HipMIPENNCT03555812
Pelvic Inclination Measurement by Navigated Ultrasound
A study testing Pelvic inclination measurement in people with Arthroplasty, Replacement, Hip, run by University Hospital, Brest at 2 sites in France.
Trial summary
Prospective, multicenter, non-randomized study. Primary endpoint : to confirm the proper functioning of the device in vivo by analyzing intra and interobserver reproducibility of repeated measurements on healthy controls. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- Pelvic inclination measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Jul 2018to 17 Jul 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For primary endpoint
- No medical or surgical history
- Major healthy voluntary topic with
- Body Mass Index (BMI) <20 for a subject
- 24 <BMI <26 for a subject
- BMI> 30 for a subject
Show all 10Show fewer
- Subject having signed an informed consent
- For the secondary endpoint
- Adult patient requiring total hip arthroplasty for severe hip osteoarthritis
- Patient having signed an informed consent
Who cannot join
- Minor subject
- Resumption of total hip prosthesis
- Subject who can not express their consent to research
- Presence of medical or surgical history for healthy volunteers
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clinique de Keraudren
Brest, 29200
Brest University Hospital
Brest, 29609
About this study
Prospective, multicenter, non-randomized study.
Primary endpoint : to confirm the proper functioning of the device in vivo by analyzing intra and interobserver reproducibility of repeated measurements on healthy controls.
Read more
Secondary endpoint : to describe the values of pelvic inclination while standing, sitting and lying in patients with severe hip osteoarthritis before and after total hip arthroplasty
After signing the inform consent form:
For the first endpoint (, 3 healthy volunteers of different morphotypes will have one consultation comprising :
- a medical examination
- 10 measurements of pelvic inclination in sitting position, 10 measurements of pelvic inclination in supine position and 10 measurements of pelvic inclination in standing position, each realized per three different operators. These measurements will be carried out with navigated ultrasound.
For the secondary endpoint, 30 patients awaiting for a hip replacement surgical intervention will realized one consultation the day before the intervention, and one consultation at 2 months after surgery, each comprising :
- a medical examination
- 3 measurements of pelvic inclination (1 standing, 1 sitting and 1 supine). These measurements will be carried out with navigated ultrasound.
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- Pelvic inclination measurement
- Keywords
- Hip, Arthroplasty, pelvic inclination, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic inclination measurementOther
Measurement of pelvic inclination per ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | * a medical examination
* 10 measurements of pelvic tilt in sitting position, 10 measurements of pelvic tilt in supine position and 10 measurements of pelvic tilt in standing position, each performed by three different operators. These measurements will be done by ultrasound. Receives: Other: Pelvic inclination measurement |
| Patients | Experimental | a consultation the day before surgery, and a consultation 2 months after surgery, each including:
* a medical examination
* 3 pelvic tilt measurements (1 standing, 1 sitting and 1 lying down). These measurements will be done by ultrasound. Receives: Other: Pelvic inclination measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic inclination measurement
The pelvic inclination measurement corresponds to the anterior pelvic plane also known as the Lewinnek's plane; defined by the plane between both anterior superior iliac spine and the pubic symphysis.
A Portable Ultrasound based Device is used for the Measurement of the Pelvic Tilt
Measured: Day 0
Secondary outcomes (1)
Variation of pelvic inclination before and after hip replacement
The pelvic inclination measurement corresponds to the anterior pelvic plane also known as the Lewinnek's plane; defined by the plane between both anterior superior iliac spine and the pubic symphysis.
A Portable Ultrasound based Device is used for the Measurement of the Pelvic Tilt
Measured: Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start18 Jul 2018
- Primary completion17 Jul 2019
- Study completion17 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, HipStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- measurements of pelvic inclination
- Masking
- None (open label)
- Enrolment
- 33 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
- NCT03555812
- Sponsor's protocol ID
- 29BRC18.0061 MIPEN
- Acronym
- MIPEN
- Status last verified
- Aug 2019
- First submitted
- 14 May 2018
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dardenne G, Pluchon JP, Letissier H, Guezou-Philippe A, Gerard R, Lefevre C, Stindel E. Accuracy and Precision of an Ultrasound-Based Device to Measure the Pelvic Tilt in Several Positions. J Ultrasound Med. 2020 Apr;39(4):667-674. doi: 10.1002/jum.15141. Epub 2019 Oct 30.
PubMed 31665548
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Inclination Measurement by Navigated Ultrasound
- ClinicalTrials.gov ID
- NCT03555812
- Acronym / sponsor ID
- MIPEN / 29BRC18.0061 MIPEN
- Conditions
- Arthroplasty, Replacement, Hip
- Keywords
- Hip, Arthroplasty, pelvic inclination, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 17 Jul 2019 (actual)
- Study completion
- 17 Jul 2019 (actual)
- First posted
- 14 Jun 2018 (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.
Prospective, multicenter, non-randomized study.
Primary endpoint : to confirm the proper functioning of the device in vivo by analyzing intra and interobserver reproducibility of repeated measurements on healthy controls.
Secondary endpoint : to describe the values of pelvic inclination while standing, sitting and lying in patients with severe hip osteoarthritis before and after total hip arthroplasty
After signing the inform consent form:
For the first endpoint (, 3 healthy volunteers of different morphotypes will have one consultation comprising :
- a medical examination
- 10 measurements of pelvic inclination in sitting position, 10 measurements of pelvic inclination in supine position and 10 measurements of pelvic inclination in standing position, each realized per three different operators. These measurements will be carried out with navigated ultrasound.
For the secondary endpoint, 30 patients awaiting for a hip replacement surgical intervention will realized one consultation the day before the intervention, and one consultation at 2 months after surgery, each comprising :
- a medical examination
- 3 measurements of pelvic inclination (1 standing, 1 sitting and 1 supine). These measurements will be carried out with navigated ultrasound.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- measurements of pelvic inclination
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Other: Pelvic inclination measurement* a medical examination * 10 measurements of pelvic tilt in sitting position, 10 measurements of pelvic tilt in supine position and 10 measurements of pelvic tilt in standing position, each performed by three different operators. These measurements will be done by ultrasound. |
| Patients | Experimental | Other: Pelvic inclination measurementa consultation the day before surgery, and a consultation 2 months after surgery, each including: * a medical examination * 3 pelvic tilt measurements (1 standing, 1 sitting and 1 lying down). These measurements will be done by ultrasound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- For primary endpoint
- No medical or surgical history
- Major healthy voluntary topic with
- Subject having signed an informed consent
- For the secondary endpoint
Key exclusion criteria (4 listed)
- Minor subject
- Resumption of total hip prosthesis
- Subject who can not express their consent to research
- Presence of medical or surgical history for healthy volunteers
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 measurementMeasurement of pelvic inclination per ultrasound | Other | Healthy volunteers, Patients |
Primary outcome
Pelvic inclination measurement
Time frame: Day 0
The pelvic inclination measurement corresponds to the anterior pelvic plane also known as the Lewinnek's plane; defined by the plane between both anterior superior iliac spine and the pubic symphysis. A Portable Ultrasound based Device is used for the Measurement of the Pelvic Tilt
1 secondary outcome
Variation of pelvic inclination before and after hip replacement
Time frame: Month 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Results publication: PubMed 31665548Dardenne G, Pluchon JP, Letissier H, Guezou-Philippe A, Gerard R, Lefevre C, Stindel E. Accuracy and Precision of an Ultrasound-Based Device to Measure the Pelvic Tilt in Several Positions. J Ultrasound Med. 2020 Apr;39(4):667-674. doi: 10.1002/jum.15141. Epub 2019 Oct 30.
- Individual participant dataSharing planned: No
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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.
2 sites 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 Arthroplasty, Replacement, Hip, run by University Hospital, Brest at 2 sites 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 10 inclusion and 4 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: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pelvic inclination measurement (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03555812, which also lists 1 linked publication.
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 3 Dec 2025.