Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT04901858
Status:
UNKNOWN
Last Update Posted:
2021-05-26
First Post:
2021-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Knee Aspiration and High Definition MRI for ACL Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-24', 'studyFirstSubmitDate': '2021-02-03', 'studyFirstSubmitQcDate': '2021-05-24', 'lastUpdatePostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pattern of injury on High Definition MRI measured by comparison with 3t MRI images', 'timeFrame': 'Last visit, usually 28 days', 'description': 'Outcome will illustrate any additional benefit of high definition MRI'}], 'secondaryOutcomes': [{'measure': 'Identification of acute inflammatory mediators measured by NanoString molecular analysis', 'timeFrame': 'Last visit, usually 28 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ACL Injury']}, 'descriptionModule': {'briefSummary': 'The aim of this pilot study is to understand the biological changes that occur within the knee joint following injury to the anterior cruciate ligament (ACL). This will be achieved through aspiration and analysis of the haemarthrosis which fills the knee following injury. The study will look at inflammatory and healing responses using DNA, RNA and protein analysis.\n\nThis, combined with high resolution imaging of the knee and surrounding soft tissue structures, may enable a more patient specific approach to treatment of ACL injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of ACL injury confirmed by MRI\n* All participants must have the capacity to provide informed consent to participate\n* Participants must be able to comply with required study visit\n\nExclusion Criteria:\n\n* Participants outside of the specified age range\n* Participants who do not have the mental capacity to make informed decisions\n* Participants who have meniscal pathology or other injuries requiring urgent surgery'}, 'identificationModule': {'nctId': 'NCT04901858', 'briefTitle': 'Knee Aspiration and High Definition MRI for ACL Injury', 'organization': {'class': 'OTHER', 'fullName': 'Cambridge University Hospitals NHS Foundation Trust'}, 'officialTitle': 'Pilot Study Into the Structural Local Molecular Environment Following an ACL Injury', 'orgStudyIdInfo': {'id': 'A095100'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Aspiration of haemarthrosis and high definition MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Aspiration of haemarthrosis and high definition MRI'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cambridge', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Stephen McDonnell', 'role': 'CONTACT', 'email': 'sm2089@cam.ac.uk', 'phone': '01223 217551'}], 'facility': 'Cambridge University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'centralContacts': [{'name': 'Stephen McDonnell', 'role': 'CONTACT', 'email': 'sm2089@cam.ac.uk', 'phone': '01223 217551'}, {'name': "Jenny O'Callaghan", 'role': 'CONTACT', 'email': 'jennifer.ocallaghan@nihr.ac.uk', 'phone': '01223 217551'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cambridge University Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mr Stephen McDonnell', 'investigatorAffiliation': 'Cambridge University Hospitals NHS Foundation Trust'}}}}