Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-02 @ 4:39 PM
Study NCT ID:
NCT03863756
Status:
UNKNOWN
Last Update Posted:
2020-06-18
First Post:
2019-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance of EOS Imaging System in the Assessment of Spondyloarthritis Structural Changes Compared With Standard Radiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D025241', 'term': 'Spondylarthritis'}], 'ancestors': [{'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-16', 'studyFirstSubmitDate': '2019-03-03', 'studyFirstSubmitQcDate': '2019-03-04', 'lastUpdatePostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intermodality agreement', 'timeFrame': '6 months', 'description': 'measuring the intermodality agreement between EOS and conventional radiography for the assessment of both the sacro-iliac joints and the spine by using 3 scores: the modified New York criteria, the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) and the Bath Ankylosing Spondylitis Radiology Index (BASRI).'}], 'secondaryOutcomes': [{'measure': 'interreader agreement', 'timeFrame': '3 months', 'description': 'measuring the interreader agreement between the radiologist and the rheumatologist for the assessement of the sacro-iliac joints and the spine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spondyloarthritis', 'spine', 'syndesmophyte', 'radiography', 'EOS'], 'conditions': ['Spondyloarthritis']}, 'referencesModule': {'references': [{'pmid': '34906697', 'type': 'DERIVED', 'citation': 'Maatallah K, Hamdi O, Bouaziz M, Lassoued H, Labbene E, Ladeb F, Kaffel D, Riahi H, Hamdi W. EOS: A new tool with weaknesses for assessing structural changes in spondyloarthritis. Joint Bone Spine. 2022 Jul;89(4):105328. doi: 10.1016/j.jbspin.2021.105328. Epub 2021 Dec 11. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Spondyloarthritis is a chronic rheumatic disease that requires prolonged radiographic follow-up. This repetitive exposure to ionizing radiation puts at risk the radiosensitive organs exposed in the field of irradiation. A new low-dose imaging system has emerged. This technique, called EOS, offers the advantage of lower irradiation associated with high images quality. Our goal through this work was to evaluate the reliability of the EOS imaging system compared to conventional radiography in the evaluation of the structural damage of SpA.', 'detailedDescription': 'Spondyloarthritis (SpA) is a chronic inflammatory disease that can affect the sacroiliac joints, the spine and / or the peripheral joints. It is characterized by a progressive and slow evolution over several years with a risk of ankylosis of the spine. It requires long-term follow-up of patients with repeated x-rays to assess structural damage. This repeated and cumulative exposure to radiation ionization puts at risk the radiosensitive organs that are in the field of irradiation.\n\nEOS is a new low dose X-ray system that significantly reduces X-ray doses compared to conventional radiography. This system allows the global assessment of the entire skeleton from head to toe, static spine and lower limbs with the obtaining of two-dimensional images of high quality with the possibility of a three-dimensional reconstruction. Although the benefits of the EOS system are promising with regard to radiation dose reduction, few studies have investigated its use in SpA and little evidence has supported its reliability in assessing the structural damage caused by the disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'General data demographics , disease characteristics \\[symptom duration, disease presentation (axial/peripheral), SpA features (psoriasis, uveitis, Human Leukocyte Antigen(HLA) B27 positivity)\\], disease activity: Bath ankylosing spondylitis disease activity index ( BASDAI) and C-reactive protein (CRP) and disease severity:Bath Ankylosing Spondylitis Functional Index (BASFI) data were collected.\n\nCR technique: All patients underwent a posteroanterior pelvic CR and a lateral and anteroposterior CR of the full spine.\n\nEOS technique: all patients undewent a full spine and pelvis 2D EOS imaging.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Spondyloarthritis (SpA) meeting the criteria of Amor and / or Assessement of spondyloarthritis International Society (ASAS)\n* Indication of standard radiography for the follow-up of the patients.\n\nExclusion Criteria:\n\n* the presence of a contraindication to the performance of conventional radiography (CR) or EOS imaging\n* any disease affecting cognition\n* Patients who have had surgery on the spine and / or hip.'}, 'identificationModule': {'nctId': 'NCT03863756', 'briefTitle': 'Performance of EOS Imaging System in the Assessment of Spondyloarthritis Structural Changes Compared With Standard Radiography', 'organization': {'class': 'OTHER', 'fullName': 'Faculty of Medicine of Tunis'}, 'officialTitle': 'Contribution of EOS in the Structural Evaluation of Spondyloarthritis', 'orgStudyIdInfo': {'id': "Institut d'orthopédie Kassab"}}, 'armsInterventionsModule': {'interventions': [{'name': 'EOS', 'type': 'RADIATION', 'otherNames': ['Standard radiography'], 'description': 'The new EOS-technology (EOS imaging, Paris, France) based on a low-dose X-ray system allows 3D modeling of the spine based on 2-dimensional'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2010', 'city': 'Tunis', 'state': 'Mannouba', 'country': 'Tunisia', 'facility': "Institut d'orthopédie Kassab", 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'overallOfficials': [{'name': 'Mataallah Kaouther, university hospital lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': "Institut d'orthopédie Kassab"}, {'name': 'Riahi Hend, university hospital lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': "Institut d'orthopédie Kassab"}, {'name': 'Hamdi Wafa, University Hospital Professor', 'role': 'STUDY_CHAIR', 'affiliation': "Institut d'orthopédie Kassab"}, {'name': 'Chelli Mouna, University Hospital Professor', 'role': 'STUDY_CHAIR', 'affiliation': "Institut d'orthopédie Kassab"}, {'name': 'Kaffel Dhia, Associate professor', 'role': 'STUDY_CHAIR', 'affiliation': "Institut d'orthopédie Kassab"}, {'name': 'Ferjani Hanene, university hospital lecturer', 'role': 'STUDY_CHAIR', 'affiliation': "Institut d'orthopédie Kassab"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculty of Medicine of Tunis', 'class': 'OTHER'}, 'collaborators': [{'name': "Institut Kassab d'Orthopédie", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Hamdi Ons', 'investigatorAffiliation': 'Faculty of Medicine of Tunis'}}}}