Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT04847258
Status:
RECRUITING
Last Update Posted:
2025-06-24
First Post:
2021-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rate of Non-copers to Non-surgical ACL Treatment After 3 Months of Rehabilitation
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 357}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2021-04-08', 'studyFirstSubmitQcDate': '2021-04-14', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients undergoing ACL reconstruction after 3 months of standard rehabilitation', 'timeFrame': '3 months', 'description': 'Patients undergoing ACL reconstruction after 3 months of standard rehabilitation are defined as non-copers to the non-surgical treatment, which will define the sensitivity and specificity of the screening examination.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anterior Cruciate Ligament Injuries']}, 'descriptionModule': {'briefSummary': 'The aim is to determine the sensitivity and specificity of a screening tool to identify patients who undergo ACL reconstruction (non-copers) after 3 months of standard rehabilitation following an anterior Cruciate ligament (ACL) injury.', 'detailedDescription': 'All included patients are referred to municipal rehabilitation to resolve effusion and range of motion deficits before the first screening (baseline screening) is completed. Hereafter the patients follow 3 months municipal rehabilitation before the second screening (3 months screening). A physiotherapist performs the screening and at the second screening, this is performed prior to consulting an orthopaedic surgeon.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be recruited from the outpatient clinic at the Department of Orthopaedic Surgery at Vejle Hospital, Denmark', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* unilateral primary ACL injury\n* Index injury no older than 6 months\n\nExclusion Criteria:\n\n* Multiligament rupture\n* Large cartillage or meniscus injuries\n* Scheduled ACL reconstruction within 3 months'}, 'identificationModule': {'nctId': 'NCT04847258', 'briefTitle': 'Rate of Non-copers to Non-surgical ACL Treatment After 3 Months of Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Vejle Hospital'}, 'officialTitle': 'Rate of Non-copers to Non-surgical ACL Treatment After 3 Months of Rehabilitation - a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'ACL screening'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Standard rehabilitation', 'type': 'OTHER', 'description': 'Patients follow standard municipal rehabilitation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '7100', 'city': 'Vejle', 'state': 'Region Syddanmark', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Kamilla Arp, MSc.', 'role': 'CONTACT', 'email': 'kamilla.dessau.arp@rsyd.dk', 'phone': '+4579406796'}, {'name': 'Claus Varnum, ph.d.', 'role': 'CONTACT', 'email': 'claus.varnum@rsyd.dk', 'phone': '+4579405779'}], 'facility': 'Vejle Hospital', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}], 'centralContacts': [{'name': 'Kamilla Arp, MSc', 'role': 'CONTACT', 'email': 'kamilla.dessau.arp@rsyd.dk', 'phone': '+45 79406796'}, {'name': 'Claus Varnum, ph.d.', 'role': 'CONTACT', 'email': 'claus.varnum@rsyd.dk', 'phone': '+45 79405779'}], 'overallOfficials': [{'name': 'Claus Varnum, ph.d.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vejle Hosptal'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vejle Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}