Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-04 @ 4:24 PM
Study NCT ID:
NCT02115451
Status:
COMPLETED
Last Update Posted:
2014-04-25
First Post:
2014-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nonsurgical or Surgical Treatment of ACL Injuries
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': 'ACTUAL', 'count': 143}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-24', 'studyFirstSubmitDate': '2014-04-14', 'studyFirstSubmitQcDate': '2014-04-14', 'lastUpdatePostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-reported knee function (IKDC 2000)', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Isokinetic knee extensor and flexor muscle strength', 'timeFrame': '2 years'}, {'measure': 'Knee reinjury', 'timeFrame': '2 years'}, {'measure': 'Participation in level I, II and III sports', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anterior Cruciate Ligament Injury']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate knee function, sports participation and knee reinjuries over 2 years in a group of patients who choose either nonsurgical or surgical treatment for an anterior cruciate ligament (ACL) injury', 'detailedDescription': "This study is a part study of an overall study with the title 'Dynamic stability of the ACL-injured knee'. The overall study prospectively follows a cohort of newly injured patients with total rupture of the anterior cruciate ligament in the knee."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Athletically active anterior cruciate ligament injured patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Anterior cruciate ligament rupture within 3 months of injury\n* Preinjury participation in level I or II sports at least twice a week\n\nExclusion Criteria:\n\n* Current or previous injury to the contralateral leg\n* Another grade III ligament injury, fracture, full-thickness articular cartilage damage'}, 'identificationModule': {'nctId': 'NCT02115451', 'briefTitle': 'Nonsurgical or Surgical Treatment of ACL Injuries', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Dynamic Stability of the ACL Deficient Knee', 'orgStudyIdInfo': {'id': '685-06289'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgical treatment', 'description': 'Patients who undergo rehabilitation and anterior cruciate ligament reconstruction, other surgical interventions may be performed'}, {'label': 'Nonsurgical treatment', 'description': 'Patients who undergo rehabilitation without anterior cruciate ligament reconstruction, other surgical interventions may be performed'}]}, 'contactsLocationsModule': {'locations': [{'zip': '0407', 'city': 'Oslo', 'state': 'Oslo County', 'country': 'Norway', 'facility': 'NAR- Department of Orthopaedics, Oslo University Hospital & Nimi', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'May Arna Risberg, PT PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian Research Center for Active Rehabilitation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Delaware', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}