Incidence of MRI Sacro-Iliac Joint Anomalies in Young Women

Axial Spondyloarthritis Clinical Trial

— MISIA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02956824
• Other study ID #: 9626
• Status: Recruiting
• Phase: N/A
• First received: August 1, 2016
• Last updated: November 2, 2016
• Start date: November 2015
• Est. completion date: May 2017

Study information

• Verified date: August 2016
• Source: University Hospital, Montpellier
• Contact: Catherine CYTEVAL, PU-PH
• Phone: 0467338178
• Email: c-cyteval[@]chu-montpellier.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Inflammatory Lesions
• Sacro-iliac Joints
• Spondylarthritis
• Structural Lesions
• Women (Between 18 to 50 Years Old)

Intervention

Other:
• Standard care
Current care

Locations

Country	Name	City	State
France	Departement of Medical Imaging	Montpellier
France	Departement of Medical Imaging	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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)	No
Secondary	Morphological analysis of sacroiliac lesions in women aged from 18-50 years old.	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	No
Secondary	Topographical analysis of sacroiliac lesions in women aged from 18-50 years old.	Topographical analysis will assess the location : Iliac versus sacral, superior vs medial vs inferior, anterior vs posterior, pubic symphysis	Time of MRI	No