Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2026-02-25 @ 6:56 PM
Study NCT ID:
NCT04185532
Status:
TERMINATED
Last Update Posted:
2024-12-20
First Post:
2019-11-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Acute ACL Injuries in Young Patients Using a Rebound ACL Brace
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The knee laxity measurement with KT-1000 will be performed by an assessor without knowledge of type of intervention. Other outcome measures will not be masked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'whyStopped': 'The study was stopped due to problems with the brace in the majority of the patients in the treatment group; such as skin lesions, non-fitting brace and severe itching. Furthermore, half of the patients went on to ACLR.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-17', 'studyFirstSubmitDate': '2019-11-25', 'studyFirstSubmitQcDate': '2019-12-02', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective knee function', 'timeFrame': '6 months', 'description': 'laxity measurement (KT-1000)'}, {'measure': 'Objective knee function', 'timeFrame': '12 months', 'description': 'laxity measurement (KT-1000)'}, {'measure': 'Objective knee function', 'timeFrame': '24 months', 'description': 'laxity measurement (KT-1000)'}, {'measure': 'objective knee function', 'timeFrame': '6 months', 'description': 'muscle strength (measured by Biodex)'}, {'measure': 'objective knee function', 'timeFrame': '12 months', 'description': 'muscle strength (measured by Biodex)'}, {'measure': 'objective knee function', 'timeFrame': '24 months', 'description': 'muscle strength (measured by Biodex)'}, {'measure': 'objective knee function', 'timeFrame': '6 months', 'description': 'jump tests'}, {'measure': 'objective knee function', 'timeFrame': '12 months', 'description': 'jump tests'}, {'measure': 'objective knee function', 'timeFrame': '24 months', 'description': 'jump tests'}], 'secondaryOutcomes': [{'measure': 'Subjective knee function', 'timeFrame': '6, 12 and 24 months', 'description': 'EQ-5D-Y'}, {'measure': 'Subjective knee function', 'timeFrame': '6, 12 and 24 months', 'description': "The Knee injury and Osteoarthritis Outcome Score for children, KOOS child. 5 subscales, where each subscale's points are calculated to a scale from 0-100; zero representing extreme knee problems and 100 representing no knee problems"}, {'measure': 'Activity level', 'timeFrame': '6, 12 and 24 months', 'description': 'Presented as Tegner activity scale. The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ACL', 'children and adolescents', 'rebound ACL brace'], 'conditions': ['Anterior Cruciate Ligament Injuries', 'Anterior Cruciate Ligament Rupture', 'Anterior Cruciate Ligament Tear']}, 'referencesModule': {'references': [{'pmid': '28053787', 'type': 'BACKGROUND', 'citation': 'Jacobi M, Reischl N, Ronn K, Magnusson RA, Gautier E, Jakob RP. Healing of the Acutely Injured Anterior Cruciate Ligament: Functional Treatment with the ACL-Jack, a Dynamic Posterior Drawer Brace. Adv Orthop. 2016;2016:1609067. doi: 10.1155/2016/1609067. Epub 2016 Dec 7.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the use of a brace in acute anterior cruciate ligament (ACL) injuries in children and adolescents. Half of the participants will receive a so called rebound ACL brace together with a standardized rehab program supervised by a physiotherapist, while the other half will receive only the standardized rehab program supervised by a physiotherapist', 'detailedDescription': 'A well known treatment of posterior cruciate ligament injuries in the acute phase is a brace which pushes the tibia anteriorly, and the result of the treatment is often successful with healing of the ligament. Similarly, in anterior cruciate ligament injuries, it is suggested that a rebound ACL brace which pushes the tibia posteriorly can facilitate healing of the ACL. It does not have as successful treatment results as the PCL brace, but the type and location of the ACL injury has in previous studies not been well defined. We will, after having described the localisation and type of ACL injury treat the intervention group with the rebound ACL brace and a standardized rehab program and the control group with standardized rehab program alone.\n\nThe randomization is made blockwise of 4, to treatment A= Brace+physiotherapy or B=Physioterapy. The groups are stratified for gender and age (\\<=14 years and \\>14 years)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'genderBased': True, 'genderDescription': 'based on self-representation of gender identity', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No previous significant knee injury\n* Trauma followed by hemarthrosis and clinical suspicion of an acute ACL injury\n* Acute ACL rupture seen on MRI\n\nExclusion Criteria:\n\n* Previous ipsilateral knee surgery\n* Associated injuries which require early surgical intervention'}, 'identificationModule': {'nctId': 'NCT04185532', 'briefTitle': 'Treatment of Acute ACL Injuries in Young Patients Using a Rebound ACL Brace', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Treatment of Acute ACL Injuries in Young Patients Using a Rebound ACL Brace', 'orgStudyIdInfo': {'id': '2018/1450-31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rebound ACL brace and physiotherapy', 'description': 'The intervention will be the use of rebound ACL brace for 9 weeks, which initially is locked followed by a gradually increased range of motion. A standardized rehab protocol is applied.', 'interventionNames': ['Other: Rebound ACL brace and physioterapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Physiotherapy', 'description': 'A standardized rehab protocol comparable to the experimental group but with no brace', 'interventionNames': ['Other: Physioterapy']}], 'interventions': [{'name': 'Rebound ACL brace and physioterapy', 'type': 'OTHER', 'description': 'Usage of rebound ACL brace and physioterapy supervised by physioterapist', 'armGroupLabels': ['Rebound ACL brace and physiotherapy']}, {'name': 'Physioterapy', 'type': 'OTHER', 'description': 'Physioterapy supervised by physioterapist', 'armGroupLabels': ['Physiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '113 41', 'city': 'Stockholm', 'state': 'Sverige', 'country': 'Sweden', 'facility': 'Capio Artro Clinic', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Frida Hansson, MD, PhD stud', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'url': 'https://staff.ki.se/ki-eln-the-electronic-notebook', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Beginning 3 months and ending minimum 5 years following article publication', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).', 'accessCriteria': 'Proposals should be directed to frida.hansson@capio.se. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Frida Hansson, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD. Principal Investigator. PhD student', 'investigatorFullName': 'Frida Hansson, MD', 'investigatorAffiliation': 'Karolinska Institutet'}}}}