Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-31 @ 3:06 PM
Study NCT ID:
NCT04222933
Status:
COMPLETED
Last Update Posted:
2021-06-22
First Post:
2020-01-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Motorized Cryotherapy on Early Effusion, Swelling, and Pain After Anterior Cruciate Ligament Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-16', 'studyFirstSubmitDate': '2020-01-05', 'studyFirstSubmitQcDate': '2020-01-07', 'lastUpdatePostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain after surgery', 'timeFrame': 'postoperative day 4', 'description': 'VAS pain scale (0 to 10 points, higher the worse pain)'}], 'secondaryOutcomes': [{'measure': 'Effusion after surgery', 'timeFrame': 'baseline, postoperative day 4, 7, 14, 6 weeks', 'description': 'Effusion by thigh circumference (cm), MRI measurement (cc)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cryotherapy Effect']}, 'descriptionModule': {'briefSummary': 'To test the efficacy of motorized cryotherapy on early effusion, and pain after ACL reconstruction', 'detailedDescription': 'To test the efficacy of motorized cryotherapy on early effusion, and pain after ACL reconstruction compared to classical ice bagging'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute ACL ruptured patient\n\nExclusion Criteria:\n\n* Combined meniscal injury requiring surgery\n* Combined ligament injury requiring surgery\n* Combined chondral injury requiring surgery\n* Previous surgery history on corresponding knee\n* Allergic to cold'}, 'identificationModule': {'nctId': 'NCT04222933', 'briefTitle': 'Effect of Motorized Cryotherapy on Early Effusion, Swelling, and Pain After Anterior Cruciate Ligament Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Hanyang University Seoul Hospital'}, 'officialTitle': 'Effect of Motorized Cryotherapy on Early Effusion, Swelling, and Pain After Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Hanyang university cryo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motorized cryotherapy', 'description': 'Application of motorized cryotherapy after ACL reconstruction for 6 postoperative days', 'interventionNames': ['Device: Motorized cryotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Classical cryotherapy', 'description': 'Application of ice bags for 6 postoperative days', 'interventionNames': ['Device: Classical cryotherapy']}], 'interventions': [{'name': 'Motorized cryotherapy', 'type': 'DEVICE', 'description': 'application of motorized cryotherapy after ACL reconstruction', 'armGroupLabels': ['Motorized cryotherapy']}, {'name': 'Classical cryotherapy', 'type': 'DEVICE', 'description': 'application of an ice bag', 'armGroupLabels': ['Classical cryotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '133-792', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Orthopaedic Surgery, Hanyang University, College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'JIN KYU LEE, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hanyang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanyang University Seoul Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'JIN KYU LEE', 'investigatorAffiliation': 'Hanyang University Seoul Hospital'}}}}