Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-31 @ 4:05 PM
Study NCT ID:
NCT05619393
Status:
UNKNOWN
Last Update Posted:
2022-11-16
First Post:
2022-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Kinematic Movements Between ACL Deficiency With ACL Reconstruction and Healthy People
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-11-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-15', 'studyFirstSubmitDate': '2022-11-01', 'studyFirstSubmitQcDate': '2022-11-15', 'lastUpdatePostDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference for 6-Degree of freedom', 'timeFrame': 'Baseline', 'description': 'Evaluate the difference in the result of measuring the six degrees of freedom of the knee joint, including the front and rear potentials of the knee joint, the inner and outer potentials, and the inner rotation/outer rotation.\n\nMeasure the vertical distance between the femur posterior condyle and posterior tibia.\n\nThe unit of measurement is millimeter .'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anterior Cruciate Ligament Injuries', 'Anterior Cruciate Ligament Reconstruction', 'Healthy People']}, 'descriptionModule': {'briefSummary': 'Comparison of kinematic movements between patients with anterior cruciate ligament rupture and post-operative patients and normal people using a mobile dynamic X-ray device.', 'detailedDescription': 'On a treadmill equipped with a mobile dynamic X-ray device, the subject will take three movements: walking, downhill walking, and squat, and the movement of the knee joint will be tracked. The investigators plan to quantify and compare the motion of the knee joint taken in patients with anterior cruciate ligament rupture, anterior cruciate ligament reconstruction, and normal people according to 6 degrees of freedom. Through this, the investigators plan to compare the functional instability between normal people and the ACL rupture patient group in daily life, and compare this with the ACL reconstruction patient group to see if surgery can reduce knee joint instability in everyday life. To confirm this, with mobile dynamic X-rays taken as the primary variable, the investigators took 1) normal subjects, 2) patients with anterior cruciate ligament rupture, 3) patients with more than 1 year after double bundle ACL reconstruction, and 4) single bundle anterior patients. the investigators plan to compare 6 degrees of freedom between patient groups who have had more than 1 year after cruciate ligament reconstruction and anterolateral ligament reconstruction. As secondary variables, the Lachman test and the Pivot shift test will be compared between the four groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Normal group\n\n 1. Adults between 19 and 60 years of age\n 2. Those who have no knee instability, locking, or jamming, and no history of surgery\n 3. A person who has the will and ability to follow the procedures of this clinical trial protocol\n 4. Those who voluntarily agreed in writing to participate in this clinical trial\n* Anterior cruciate ligament rupture patient group\n\n 1. Adults between 19 and 60 years of age\n 2. Those with grade 3 or higher in the Lachmann test\n 3. A person suspected of having an anterior cruciate ligament injury tear on magnetic resonance imaging (MRI)\n 4. A person who has the will and ability to follow the procedures of this clinical trial protocol\n 5. Those who voluntarily agreed in writing to participate in this clinical trial\n* Patient group more than 1 year after anterior cruciate ligament reconstruction\n\n 1. Adults between 19 and 60 years of age\n 2. A person who has performed double bundle reconstruction; or Those who have performed single bundle reconstruction and anterolateral ligament reconstruction\n 3. A person who has the will and ability to follow the procedures of this clinical trial protocol\n 4. Those who voluntarily agreed in writing to participate in this clinical trial\n\nExclusion criteria\n\n1. Those with degenerative arthritis of the knee joint\n2. Those who need reoperation after anterior cruciate ligament rupture surgery, or those who have other knee surgery history, who are difficult to participate in the study under the judgment of the principal investigator\n3. Patients with chronic inflammatory joint disease such as rheumatoid arthritis\n4. Those whose growth plates are not closed\n5. Patients who need companion surgery for ligament instability of grade II (grade 0: none, grade I: 0-5 mm, grade II: 5-10 mm, grade III: \\>10 mm) on physical examination\n6. Pregnant and lactating women\n7. Persons judged by other researchers as inappropriate for participation in clinical trials'}, 'identificationModule': {'nctId': 'NCT05619393', 'briefTitle': 'Comparison of Kinematic Movements Between ACL Deficiency With ACL Reconstruction and Healthy People', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Comparison of Kinematic Movements Between ACL Deficiency With ACL Reconstruction and Healthy People - Investigator Initiated Trial-', 'orgStudyIdInfo': {'id': '2022-05-019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mobilie Bi-planar X-ray Imaging system', 'interventionNames': ['Device: Mobilie Bi-planar X-ray Imaging system']}], 'interventions': [{'name': 'Mobilie Bi-planar X-ray Imaging system', 'type': 'DEVICE', 'description': 'on the Mobilie Bi-planar X-ray Imaging system, images are acquired for three movements: walking, downhill walking, and squat', 'armGroupLabels': ['Mobilie Bi-planar X-ray Imaging system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Joon Ho Wang, MD', 'role': 'CONTACT', 'email': 'mdwang88@gmail.com', 'phone': '+82-2-3410-3507'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wang Joon Ho', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, Professor, Department of Orthopaedic Surgery', 'investigatorFullName': 'Wang Joon Ho', 'investigatorAffiliation': 'Samsung Medical Center'}}}}