Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT04944693
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-11-22
First Post:
2021-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relationship Between Anterior Tibial Subluxation and the Prognosis of Anterior Cruciate Ligament Reconstruction.
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': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2021-06-27', 'studyFirstSubmitQcDate': '2021-06-27', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients reported outcomes', 'timeFrame': 'at least 1-year postoperatively', 'description': '(i.e. Lysholm score, etc.)'}], 'secondaryOutcomes': [{'measure': 'MRI images', 'timeFrame': 'at least 1-year postoperatively', 'description': 'Anterior tibial subluxation were measured on postoperative MRI images'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anterior tibial subluxation'], 'conditions': ['Anterior Cruciate Ligament Injuries']}, 'descriptionModule': {'briefSummary': 'To identify the improvement of anterior tibial subluxation (ATS) and the relationship between ATS and patient reported outcome on pre- and postoperative anterior cruciate ligament-injured MRI images.', 'detailedDescription': 'The value of preoperative anterior tibial subluxation (ATS) was used for the division of anterior cruciate ligament-injured patients in 2 groups. ATS was measured on pre- and postoperative MRI images. Patients were followed up 2 years after anterior cruciate ligament reconstruction, and patient reported outcomes (i.e. Lysholm score, etc.) were collected for further analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'anterior cruciate ligament-injured patients that had suffered from anterior cruciate ligament injury.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: (1) Diagnosed anterior cruciate ligament injuries; (2) available preoperative MRI scans at our hospital.\n\n\\-\n\nExclusion Criteria: Patients were excluded in the case of under 18 years of age, bilateral anterior cruciate ligament injuries, concomitant posterior cruciate ligament injuries, concomitant collateral ligament injuries, and no access to the preoperative MRI scan at our hospital.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04944693', 'briefTitle': 'Relationship Between Anterior Tibial Subluxation and the Prognosis of Anterior Cruciate Ligament Reconstruction.', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'A Prospective Study of Anterior Tibial Subluxation in the Setting of Anterior Cruciate Ligament Reconstruction With 2-year Follow-up', 'orgStudyIdInfo': {'id': 'M2020384'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Anterior cruciate ligament-injured patients with excessive ATS', 'interventionNames': ['Other: Different ATS values.']}, {'label': 'Cohort 2', 'description': 'Anterior cruciate ligament-injured patients with minimal ATS', 'interventionNames': ['Other: Different ATS values.']}], 'interventions': [{'name': 'Different ATS values.', 'type': 'OTHER', 'description': 'Observational, different ATS values were measured on MRI images and were regarded as "interventions" for different cohorts.', 'armGroupLabels': ['Cohort 1', 'Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Cheng Wang, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}