Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2025-12-30 @ 6:57 AM
Study NCT ID:
NCT05752695
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-06
First Post:
2023-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Operation Korsband
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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-02', 'studyFirstSubmitDate': '2023-02-21', 'studyFirstSubmitQcDate': '2023-02-21', 'lastUpdatePostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total work load', 'timeFrame': 'Day 1', 'description': 'Total hours, per week, of practice and games.'}], 'secondaryOutcomes': [{'measure': 'Number of teams', 'timeFrame': 'Day 1', 'description': 'In team athletes, the number of teams in which the athlete participates.'}, {'measure': 'Injury situation 1', 'timeFrame': 'Day 1', 'description': 'Question regarding when the injury occurred; training vs game.'}, {'measure': 'Injury situation 2', 'timeFrame': 'Day 1', 'description': 'Question regarding at what situation the injury occurred (e.g. jump, landing, header duel, defense, attack...)'}, {'measure': 'Injury situation 3', 'timeFrame': 'Day 1', 'description': 'Question regarding at what time, during a game, the injury occurred; approximate match minute'}, {'measure': 'Physical well-being', 'timeFrame': 'Day 1', 'description': "Physical well-being is assessed with a likert scale ranging from 1-5 where '1' represents 'out of shape' while '5' represents that you felt 'in top shape'."}, {'measure': 'Mental wellbeing', 'timeFrame': 'Day 1', 'description': "Mental well-being is assessed with a likert scale ranging from 1-5 where '1' represents 'out of shape' while '5' represents that you felt 'in top shape'."}, {'measure': 'Previous injury', 'timeFrame': 'Day 1', 'description': 'Description of previous injury prior to the ACL injury, such as other injuries to lower extremity or concussion.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anterior Cruciate Ligament Injuries']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate if a detailed and comprehensive survey can identify, explain and prevent the risk factors for ACL injury.\n\nA a new questionnaire has been developed with questions to young athletes who have suffered an anterior cruciate ligament injury. The questionnaire is more detailed and provide more information about how the anterior cruciate ligament injury occurred compared with the questionnaires currently available in the literature. This careful documentation will provide new knowledge and might be used to identify, explain and prevent risk factors that cause young athletes to suffer an anterior cruciate ligament injury.', 'detailedDescription': 'Participants will be prospectively recruited at their first physiotherapist clinical session. On this occasion, participants will be asked to fill in a questionnaire regarding injury situation, game or training, sex, age, sport affiliation, level of sport, other aspects of sport such as participation in several teams and junior versus senior games/training. In addition, questions regarding previous injury will also be documented.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Athletes with ACL defined ACL injury.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Athlete\n* Defined ACL injury\n\nExclusion Criteria:\n\n* Non athletes\n* Younger than 12 years'}, 'identificationModule': {'nctId': 'NCT05752695', 'briefTitle': 'Operation Korsband', 'organization': {'class': 'OTHER', 'fullName': 'Linnaeus University'}, 'officialTitle': 'Risk Factors for Cruciate Ligament Injuries', 'orgStudyIdInfo': {'id': '2022-06554-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ACL injured athletes', 'description': 'Athletes with defined ACL injury.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '391 82', 'city': 'Kalmar', 'country': 'Sweden', 'facility': 'Sofia Ryman Augustsson', 'geoPoint': {'lat': 56.66157, 'lon': 16.36163}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linnaeus University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kalmar County Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sofia Ryman Ryman Augustsson', 'investigatorAffiliation': 'Linnaeus University'}}}}