Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:32 PM
Study NCT ID:
NCT07386405
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-04
First Post:
2026-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation and Cultural Adaptation of the KOOS-ACL Scale for the Italian Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-19', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-27', 'studyFirstSubmitDate': '2026-01-27', 'studyFirstSubmitQcDate': '2026-01-27', 'lastUpdatePostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'validated translation and cultural adaptation of the KOOS-ACL scale in Italian.', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['scale reliability', 'ACL', 'KOOS-ACL', 'PROMs'], 'conditions': ['Scale Reliability Validity', 'ACL Injury', 'Validation and Cultural Adaptation of a Scale', 'PROMs']}, 'descriptionModule': {'briefSummary': 'Submission of the KOOS ACL questionnaires in Italian for the purpose of validation and cultural adaptation of the KOOS-ACL scale for the Italian population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a diagnosis of anterior cruciate ligament injury, undergoing or being considered for ACL reconstruction surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient age 18 years or older\n* Patients who are native Italian speakers\n* Patients undergoing anterior cruciate ligament reconstruction of the knee\n* Patients who have understood and signed the informed consent to participate in the study.\n* Patients who are able to understand the study conditions and participate for the entire duration\n\nExclusion Criteria:\n\n* Patients unable to understand the text in Italian\n* Patients undergoing knee replacement surgery, corrective osteotomies, or osteosynthesis of knee fractures.\n* Patients who are drug addicts, alcoholics, suffer from psychiatric disorders, or have any clinical conditions that could compromise the success of the questionnaire.\n* Patients with orthopedic conditions of other origins'}, 'identificationModule': {'nctId': 'NCT07386405', 'acronym': 'VACKP', 'briefTitle': 'Validation and Cultural Adaptation of the KOOS-ACL Scale for the Italian Population', 'organization': {'class': 'OTHER', 'fullName': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio"}, 'officialTitle': 'Italian Version of KOOS-ACL (Knee Injury and Osteoarthritis Outcomes Score - Anterior Cruciate Ligament): Translation, Cross-cultural Adaptation and Validation', 'orgStudyIdInfo': {'id': 'KOOS-ACL Validation (VACKP)'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PROMS submition', 'type': 'OTHER', 'description': 'KOOS ACL submission to validate and transalte the scale for italian people'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto Clinico San Siro', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}