Is the Dynamic of the Pelvic Bone Altered After a Total Hip Replacement ? (NCT04587440) | Clinical Trial Compass
TerminatedNot Applicable
Is the Dynamic of the Pelvic Bone Altered After a Total Hip Replacement ?
France15 participantsStarted 2021-02-02
Plain-language 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.
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial has been terminated, can you tell me what that means for our understanding of how the pelvis changes after hip replacement surgery, and whether the results were ever published or shared?
2This study was focused on measuring something called 'pelvic incidence' after a total hip replacement — can you explain what pelvic incidence is and why changes to it might matter for my recovery or long-term outcomes?
3Because this trial was terminated before completing, are there other ongoing or completed studies you know of that address how pelvic bone movement is affected after a total hip replacement?
4Whether my hip arthritis is considered primary or secondary coxarthrosis seems to have been relevant to this study — does the distinction between those two types affect what I should expect from a hip replacement in my specific case?
5Since this was a non-interventional study measuring pelvic dynamics rather than testing a new treatment, what does current evidence tell you about whether pelvic alignment issues are something we should monitor closely after my hip replacement?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.