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Is the Dynamic of the Pelvic Bone Altered After a Total Hip Replacement ?

Is the Dynamic of the Pelvic Bone Altered After a Total Hip Replacement ?

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04587440
Acronym
DYPAMAT
Enrollment
15
Registered
2020-10-14
Start date
2021-02-02
Completion date
2022-02-26
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coxarthrosis; Primary, Coxarthrosis; Secondary

Brief 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.

Interventions

Ultra-sound based measurements of the pelvic inclination lying, standing and seating position. EOX X-ray in seating position.

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Study of the variation of the dynamic of the pelvic bone in pre and post operative of a hip replacement

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Variation of the pelvic incidenceDay 0 - Month 3The main evaluation criterion is the variation of the pelvic incidence between pre- and post-operative total hip replacements

Secondary

MeasureTime frameDescription
Analysis of the correlation between the variation in pelvic incidence while sitting, standing and lying down and the implant settingsDay 0 - Month 3Assessed by EOS X-Ray.
Analysis of the correlation between variation in pelvic incidence while sitting, standing and lying down and clinical parameters (Harris hip score)Day 0 - Month 3Clinical examination (Harris hip score) will be performed at day 0 and month 3.
Analysis of the correlation between variation in pelvic incidence while sitting, standing and lying down and clinical parameters (EVA)Day 0 - Month 3Clinical examination (EVA) will be performed at day 0 and month 3.
Analysis of the correlation between variation in pelvic incidence while sitting, standing and lying down and clinical parameters (Hand-ground distance)Day 0 - Month 3Clinical examination (Hand-ground distance) will be performed at day 0 and month 3.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026