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Incidence of MRI Sacro-Iliac Joint Anomalies in Young Women (MISIA)

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ClinicalTrials.gov Identifier: NCT02956824
Recruitment Status : Unknown
Verified August 2016 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : November 7, 2016
Last Update Posted : November 7, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

Prospective multicenter study assessing the incidence of inflammatory and structural lesions seen on MRI of the SI joints in a consecutive population of women aged 18-50 years old.

The study hypothesis is SpA may be misdiagnosed on MRI in post partum women due to increased stress on the joint following pregnancy and childbirth, as MRI of the SI joints may show lesions that could mimics axial spondyloarthritis. The primary objective of this study is to determine the incidence of SI lesions seen at MRI in women. The secondary objectives are to compare the incidence and pattern of MRI inflammatory and structural lesions of the SI joints and to determine the factors associated with inflammatory or structural changes of the SI joints in a population of women. the investigators will especially compare the population of women within a year after childbirth versus the population of women who never gave birth or who gave birth over 24 months ago or more.


Condition or disease Intervention/treatment Phase
Women (Between 18 to 50 Years Old) Sacro-iliac Joints Inflammatory Lesions Structural Lesions Axial Spondyloarthritis Other: Standard care Not Applicable

Detailed Description:

500 women aged of 18 to 50 years old, including 100 women who gave birth within the year, referred to the Imaging department for pelvic MRI for the exploration of pelvic or gynecologic pathology will be recruited consecutively.

MRI will be performed on a 1.5 T MRI according to standardized exploration of the pelvis and will include axial T1-weighted sequences and T2STIR (or T2 fat sat or T2 Dixon) of maximum 6 mm thickness .

An additional Axial STIR sequence may be added as part of the research (duration 3 minutes), if the standard protocol does not include any STIR, T2 fat sat T2 or T2 Dixon sequence.

SI lesions will be assessed in a centralized randomized and independent review of all MR images by 2 musculoskeletal radiologists according to ASAS criteria.

Patients will complete a standardized questionnaire on the day of MRI to collect the following data : patient's and family history of chronic inflammatory disease, number and date of pregnancies, practice of sports, back pain, joint pain.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Incidence of Sacro-Iliac Joint Anomalies on MRI in Women Aged From 18 to 50 Years Old
Study Start Date : November 2015
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017

Intervention Details:
  • Other: Standard care
    Current care


Primary Outcome Measures :
  1. Presence of MRI inflammatory and structural lesions of the sacroiliac joints (including pubic symphysis) in the population of women who gave birth within the past 12 months. [ Time Frame: Time of MRI (within the year following childbirth or pregnancy) ]

    MRI Lesions will be analyzed according to ASAS criteria. Inflammatory lesions will be evaluated on STIR (or T2 fat sat or T2 dixon) sequences.

    Structural lesions will be evaluated on T1 weighted sequences



Secondary Outcome Measures :
  1. Morphological analysis of sacroiliac lesions in women aged from 18-50 years old. [ Time Frame: Time of MRI ]
    Morphological analysis will evaluate erosion, fat, condensation, bone marrow edema using a 3 point scale (0-mild-high) for their number or extension.

  2. Topographical analysis of sacroiliac lesions in women aged from 18-50 years old. [ Time Frame: Time of MRI ]
    Topographical analysis will assess the location : Iliac versus sacral, superior vs medial vs inferior, anterior vs posterior, pubic symphysis



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Women aged 18 to 50 years old
  • MRI of the pelvis requested as part of an exploration of a gynecological or pelvic pathology
  • Women who delivered within the year OR women who never gave birth or gave birth 24 months ago and over

Exclusion criteria:

  • Patients with a personal or family history of inflammatory disease (SpA , ulcerative colitis , chron , PSO , RA, SAPHO)
  • Patients with a history of trauma or surgery of the pelvis
  • Pregnant women
  • Women who gave birth over a year ago and less than 2 years ago

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956824


Contacts
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Contact: Catherine CYTEVAL, PU-PH 0467338178 c-cyteval@chu-montpellier.fr

Locations
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France
Departement of Medical Imaging Recruiting
Montpellier, France, 34295
Contact: Catherine CYTEVAL, PU-PH    0467338178    c-cyteval@chu-montpellier.fr   
Contact: Sophie LEFEBVRE, CRA    0467338607    s-lefebvfre@chu-montpellier.fr   
Departement of Medical Imaging Recruiting
Montpellier, France, 34295
Contact: Catherine CYTEVAL, PU-PH    0467338178    c-cyteval@chu-montpellier.fr   
Contact: Mégane BOIXIERE, CRA    0467338607    m-boixieremarconnet@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Catherine CYTEVAL Montpellier University Hospital

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02956824     History of Changes
Other Study ID Numbers: 9626
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University Hospital, Montpellier:
Magnetic Resonance Imaging (MRI)
Sacro-iliac joints
Pelvis
Erosion
Fat deposit
Subchondral sclerosis
Bone marrow edema
Axial spondyloarthritis
Additional relevant MeSH terms:
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Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases