Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-02-24 @ 12:13 PM
Study NCT ID:
NCT01249612
Status:
TERMINATED
Last Update Posted:
2012-07-19
First Post:
2010-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Knee Joint Icing and Knee-extension Strength
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D017679', 'term': 'Cryotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-18', 'studyFirstSubmitDate': '2010-11-23', 'studyFirstSubmitQcDate': '2010-11-29', 'lastUpdatePostDateStruct': {'date': '2012-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee-extension strength', 'timeFrame': 'In the first week after surgery patients are measured on two days: One day before and after active (knee icing) treatment and one day before and after control (elbow icing) treatment', 'description': 'Maximal knee-extension strength is measured using a hand-held dynamometer'}], 'secondaryOutcomes': [{'measure': 'Knee pain', 'timeFrame': 'In the first week after surgery patients are measured on two days: One day before and after active (knee icing) treatment and one day before and after control (elbow icing) treatment', 'description': 'Knee pain was quantified by using The Visual Analog Scale (VAS) at rest and during active measurements.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Knee joint icing', 'knee-extension strength'], 'conditions': ['Arthroplasty']}, 'referencesModule': {'references': [{'pmid': '22261815', 'type': 'DERIVED', 'citation': 'Holm B, Husted H, Kehlet H, Bandholm T. Effect of knee joint icing on knee extension strength and knee pain early after total knee arthroplasty: a randomized cross-over study. Clin Rehabil. 2012 Aug;26(8):716-23. doi: 10.1177/0269215511432017. Epub 2012 Jan 19.'}]}, 'descriptionModule': {'briefSummary': 'With this study the investigators wish to (1) investigate the acute effect of knee joint icing on knee-extension strength shortly after total knee arthroplasty (TKA); and (2) investigate the acute effect of knee joint icing on knee pain, knee joint circumference and functional performance shortly after TKA.', 'detailedDescription': 'As knee joint icing had no acute effect on knee-extension strength in the present study, prolonged icing may have an effect on one or more of the parameters, and further studies are needed to determine the potential beneficial effects of cooling after TKA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary unilateral total knee arthroplasty\n\nExclusion Criteria:\n\n* inability to speak and understand Danish\n* inability to perform the measurements due to other diseases'}, 'identificationModule': {'nctId': 'NCT01249612', 'acronym': 'IS', 'briefTitle': 'Knee Joint Icing and Knee-extension Strength', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'No Effect of Knee Joint Icing on Knee-extension Strength After Total Knee Arthroplasty. A Randomized Cross-over Study', 'orgStudyIdInfo': {'id': '(H-A-2008-063, nr. 24100'}, 'secondaryIdInfos': [{'id': 'TKA-BH3', 'type': 'REGISTRY', 'domain': 'H-A-2008-063'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control treatment', 'description': 'Elbow joint icing using two plastic bags with crushed ice', 'interventionNames': ['Other: Thermotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active treatment', 'description': 'Knee joint icing using two plastic bags with crushed ice', 'interventionNames': ['Other: Thermotherapy']}], 'interventions': [{'name': 'Thermotherapy', 'type': 'OTHER', 'otherNames': ['Cryotherapy'], 'description': 'Knee joint icing', 'armGroupLabels': ['Active treatment']}, {'name': 'Thermotherapy', 'type': 'OTHER', 'otherNames': ['Cryotherapy'], 'description': 'Elbow joint icing', 'armGroupLabels': ['Control treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Copenhagen', 'state': 'Hvidovre', 'country': 'Denmark', 'facility': 'The Lundbeckcenter for fast-track hip and knee surgery', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Bente Holm, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Orthopaedic Surgery, University Hospital at Hvidovre, Kettegaard Alle 30, DK-2650 Hvidovre, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lundbeck Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc PT', 'investigatorFullName': 'Bente Holm', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}