Axial Spondyloarthritis Clinical Trial
— MISIAOfficial title:
Incidence of Sacro-Iliac Joint Anomalies on MRI in Women Aged From 18 to 50 Years Old
NCT number | NCT02956824 |
Other study ID # | 9626 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 16, 2015 |
Est. completion date | May 27, 2019 |
Verified date | May 2024 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 512 |
Est. completion date | May 27, 2019 |
Est. primary completion date | May 27, 2019 |
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 |
Country | Name | City | State |
---|---|---|---|
France | Departement of Medical Imaging | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
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) | |
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 | |
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 |
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