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NCT Number: NCT02956824

Incidence of MRI Sacro-Iliac Joint Anomalies in Young Women

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.

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Key information

Conditions

Women (Between 18 to 50 Years Old) Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Inflammatory Lesions Joint Diseases Musculoskeletal Diseases Sacro-iliac Joints Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Structural Lesions

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Departement of Medical Imaging

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard care

Other

Current care

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Incidence of Sacro-Iliac Joint Anomalies on MRI in Women Aged From 18 to 50 Years Old

Acronym: MISIA

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Nov 7, 2016
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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