Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2026-02-24 @ 3:52 AM
Study NCT ID:
NCT06068595
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-05
First Post:
2023-09-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Contribution of Musculoskeletal Ultrasound to the General Practitioner's Overall Decision-making Strategy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-28', 'studyFirstSubmitDate': '2023-09-22', 'studyFirstSubmitQcDate': '2023-09-28', 'lastUpdatePostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients', 'timeFrame': '3 years', 'description': "Percentage of patients for whom the musculoskeletal point of care ultrasonography led to a change in the GP's overall decision-making strategy (binary yes/no variable) of patients for whom led to a change in the GP's overall decision-making strategy (binary yes/no variable)"}], 'secondaryOutcomes': [{'measure': 'Frequency of the anatomical sites', 'timeFrame': '3 years', 'description': 'Frequency of the different anatomical sites (shoulder, elbow, arm, etc.) and structures (osteoarticular pathologies, tendon and retinacular pathologies, etc.) concerned'}, {'measure': 'Frequency of modifications', 'timeFrame': '3 years', 'description': 'Frequency of different modifications for each axis and within each axis'}, {'measure': 'Frequency of diagnoses of post-CTA confirmation', 'timeFrame': '3 years', 'description': 'List and frequency of diagnoses in the case of post-CTA confirmation'}, {'measure': 'Frequency of diagnoses of post-CTA modifications', 'timeFrame': '3 years', 'description': 'List and frequency of diagnoses in the case of post-CTA modifications'}, {'measure': 'Frequency of incidental diagnoses discovered at CTA', 'timeFrame': '3 years', 'description': 'Frequency and description of incidental diagnoses discovered at CTA'}, {'measure': 'Frequency of modifications per patient', 'timeFrame': '3 years', 'description': 'Frequency of different modifications for each axis and within each axis per patient'}, {'measure': 'Calculation of the cost', 'timeFrame': '3 years', 'description': 'Calculation of the cost before and after CTA estimated a posteriori on the basis of the consultation rate'}, {'measure': 'Rates for the examinations and therapies', 'timeFrame': '3 years', 'description': 'the rates for the examinations and therapies described'}, {'measure': 'Frequency with which CTA', 'timeFrame': '3 years', 'description': 'For each doctor: the frequency with which CTA is carried out in his professional practice'}, {'measure': 'Time taken to carry out the CTA', 'timeFrame': '3 years', 'description': 'For each doctor: the time taken to carry out the CTA'}, {'measure': 'Average number of ultrasound prints', 'timeFrame': '3 years', 'description': 'For each doctor: the average number of ultrasound image prints'}, {'measure': 'Time taken to produce an CTA report', 'timeFrame': '3 years', 'description': 'For each doctor: the time taken to produce an CTA report'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['musculoskeletal anomaly', 'ultrasonography', 'general practitioners'], 'conditions': ['Musculoskeletal; Anomaly']}, 'referencesModule': {'references': [{'pmid': '31749019', 'type': 'BACKGROUND', 'citation': 'Sorensen B, Hunskaar S. Point-of-care ultrasound in primary care: a systematic review of generalist performed point-of-care ultrasound in unselected populations. Ultrasound J. 2019 Nov 19;11(1):31. doi: 10.1186/s13089-019-0145-4.'}, {'pmid': '33675099', 'type': 'BACKGROUND', 'citation': 'Meyer R, Lin C, Yenokyan G, Ellen M. Diagnostic Utility of Ultrasound Versus Physical Examination in Assessing Knee Effusions: A Systematic Review and Meta-analysis. J Ultrasound Med. 2022 Jan;41(1):17-31. doi: 10.1002/jum.15676. Epub 2021 Mar 5.'}, {'pmid': '18492916', 'type': 'BACKGROUND', 'citation': 'Nazarian LN. The top 10 reasons musculoskeletal sonography is an important complementary or alternative technique to MRI. AJR Am J Roentgenol. 2008 Jun;190(6):1621-6. doi: 10.2214/AJR.07.3385.'}, {'pmid': '29490335', 'type': 'BACKGROUND', 'citation': 'Narula J, Chandrashekhar Y, Braunwald E. Time to Add a Fifth Pillar to Bedside Physical Examination: Inspection, Palpation, Percussion, Auscultation, and Insonation. JAMA Cardiol. 2018 Apr 1;3(4):346-350. doi: 10.1001/jamacardio.2018.0001.'}, {'pmid': '31253102', 'type': 'BACKGROUND', 'citation': 'Andersen CA, Davidsen AS, Brodersen J, Graumann O, Jensen MB. Danish general practitioners have found their own way of using point-of-care ultrasonography in primary care: a qualitative study. BMC Fam Pract. 2019 Jun 28;20(1):89. doi: 10.1186/s12875-019-0984-x.'}]}, 'descriptionModule': {'briefSummary': "The hypothesis of this study is that musculoskeletal point of care ultrasonography would support the GP's decision and ultimately improve patient management.\n\nThe aim of this study is to evaluate, in the context of suspected musculoskeletal abnormality, the contribution of musculoskeletal point of care ultrasonography to the general practitioner's overall decision-making strategy, defined according to the following 5 axes: diagnosis (I), therapy (II), patient orientation (III), prescription of complementary examinations (IV) and follow-up (V).", 'detailedDescription': 'The study circuit takes place in a single visit.\n\n1. The investigating physician suspects a musculoskeletal anomaly following an initial clinical examination.\n2. The patient (who meets the inclusion criteria and has no non-inclusion criteria) gives consent to participate, after receiving information about the study.\n3. The investigator fills in the e-CRF (appendix III), clinical examination, medical interrogation and his or her decisions according to the 5 axes, which cannot be modified, as the structure of the e-CRF planned in advance does not allow backtracking. The investigator performs the targeted musculoskeletal ultrasound with his or her personal ultrasound machine, following his or her usual operating procedure.\n4. The investigator fills in the e-CRF with the results of the targeted ultrasound scan and indicates any modifications to the decision axes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Person who has received full information on the organization of the research and has given his/her consent\n* Be over 18 years of age\n* Present a symptomatology leading to suspicion of musculoskeletal pathology\n* Be able to give consent\n* Be affiliated to a social security scheme or benefit from such a scheme\n\nExclusion Criteria:\n\n* Chronic inflammatory rheumatism (rheumatoid arthritis, spondylitis, psoriatic arthritis, rheumatoid pseudo-polyarthritis, juvenile idiopathic arthritis, lupus, etc.).\n* Subjects benefiting from a legal protection measure (guardianship, curatorship, safeguard of justice).\n* Persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care under articles L3212-1 and L3213-1.\n* Pregnant women\n* Nursing mothers'}, 'identificationModule': {'nctId': 'NCT06068595', 'acronym': 'ECHOSTEOM', 'briefTitle': "Evaluation of the Contribution of Musculoskeletal Ultrasound to the General Practitioner's Overall Decision-making Strategy", 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': "The Contribution of Targeted Musculoskeletal Ultrasound to the General Practitioner's Overall Decision-making Strategy for Patients With Suspected Musculoskeletal Pathology: a Before/After Study", 'orgStudyIdInfo': {'id': '2023-A01995-40'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients', 'description': 'Patient with musculoskeletal anomalies', 'interventionNames': ['Other: musculoskeletal ultrasound']}], 'interventions': [{'name': 'musculoskeletal ultrasound', 'type': 'OTHER', 'description': 'After clinical examination and medical interrogation, The investigating physician gives her decisions in the e-CRF according to the 5 axes: diagnosis (I), therapy (II), patient referral (III), prescription of additional tests (IV) and follow-up (V). The investigator performs the targeted musculoskeletal ultrasound with his personal ultrasound machine, following his usual operating procedure and give/keep the final diagnostic.', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Nancy', 'state': 'Vandoeuvre Lès Nancy', 'country': 'France', 'contacts': [{'name': 'Boris Gass, Dr', 'role': 'CONTACT', 'email': 'boris.gass@univ-lorraine.fr'}, {'name': 'Paolo Di Patrizio, Pr', 'role': 'CONTACT', 'email': 'paolo.di-patrizio@univ-lorraine.fr'}], 'facility': 'Central Hospital', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'centralContacts': [{'name': 'Boris Gass, Dr', 'role': 'CONTACT', 'email': 'boris.gass@univ-lorraine.fr', 'phone': '67467111', 'phoneExt': '33'}, {'name': 'Paolo Di Patrizio, Pr', 'role': 'CONTACT', 'email': 'paolo.di-patrizio@univ-lorraine.fr', 'phone': '608376920', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'Boris Gass, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Hospital, Nancy, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Lorraine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'GASS Boris', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}