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

November 2, 2016 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time of MRI (within the year following childbirth or pregnancy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time of MRI
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
Time of MRI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Catherine CYTEVAL, Montpellier University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (ANTICIPATED)

May 1, 2017

Study Completion (ANTICIPATED)

May 1, 2017

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

November 2, 2016

First Posted (ESTIMATE)

November 6, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

November 6, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9626

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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