Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-03-08 @ 1:59 AM
Study NCT ID:
NCT01612702
Status:
COMPLETED
Last Update Posted:
2013-05-27
First Post:
2012-06-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Single, Low-dose Dexamethasone in Patients After Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'osktk@snubh.org', 'phone': '82-31-787-7196', 'title': 'Dr. TK Kim', 'phoneExt': '7200', 'organization': 'Joint Reconstruction Center, Seoul National University Bundang Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '30 days after total knee arthroplasty', 'description': 'wound complication such as postoperative infection, wound dehescence.', 'eventGroups': [{'id': 'EG000', 'title': 'Dexamethasone', 'description': 'dexamethasone 10 mg administration 1 hour before surgery', 'otherNumAtRisk': 146, 'otherNumAffected': 0, 'seriousNumAtRisk': 146, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Control', 'description': 'No dexamethasone', 'otherNumAtRisk': 145, 'otherNumAffected': 0, 'seriousNumAtRisk': 145, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Wound complication', 'notes': 'wound compltications within 30 days after total knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Nausea and Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone', 'description': 'dexamethasone 10 mg administration 1 hour before surgery'}, {'id': 'OG001', 'title': 'Control', 'description': 'No dexamethasone'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '22.8', 'upperLimit': '25.2'}, {'value': '40', 'groupId': 'OG001', 'lowerLimit': '38', 'upperLimit': '42'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 72 hours after surgery', 'description': 'A clinical investigator who is blinded to randomization assessed the incidence of postoperative nausea which defined as subjective unpleasant sensation associated with awareness of the urge to vomit and as emetic episode and vomiting', 'unitOfMeasure': 'percentage of participant', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone', 'description': 'dexamethasone 10 mg administration 1 hour before surgery'}, {'id': 'OG001', 'title': 'Control', 'description': 'No dexamethasone'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 to 24 hours after surgery', 'description': 'A blinded investigator asked participants to recall the most severe pain level during 6 to 24 hour after surgery using with a visual analogue scale that ranged from 0 (no pain) to 10 (worst imaginable pain).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Wound Complication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone', 'description': 'dexamethasone 10 mg administration 1 hour before surgery'}, {'id': 'OG001', 'title': 'Control', 'description': 'No dexamethasone'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 30 days after surgery', 'description': 'Number of participants with a sinus tract communicating with the prosthesis; a pathogen was isolated by culture from tissue or fluid samples taken from the affected joint; tests revealed elevated serum erythrocyte sedimentation rate (ESR) or serum C-reactive protein (CRP) concentration with elevated synovial white blood cell (WBC) count or neutrophil percentage; or pus discharge from the affected joint was present within 30 days after total knee arthroplasty were measured.', 'unitOfMeasure': 'participant', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dexamethasone', 'description': 'dexamethasone 10 mg administration 1 hour before surgery'}, {'id': 'FG001', 'title': 'Control', 'description': 'No dexamethasone'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '146'}, {'groupId': 'FG001', 'numSubjects': '145'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '134'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}], 'recruitmentDetails': '305 patients who were scheduled for unilateral total knee arthroplasty at Seoul National Bundang Hospital from April 2011 to December 2011 were recruited.', 'preAssignmentDetails': '14 patients were excluded before assignment. 5 were other diagnosis such as rheumatoid arthritis, secondary osteoarthritis, 4 had serious medical conditions such as renal failure, heary failure, 5 refused to participate'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '291', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dexamethasone', 'description': 'dexamethasone 10 mg administration 1 hour before surgery'}, {'id': 'BG001', 'title': 'Control', 'description': 'No dexamethasone'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '263', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72', 'spread': '6.7', 'groupId': 'BG000'}, {'value': '72', 'spread': '6.2', 'groupId': 'BG001'}, {'value': '72', 'spread': '6.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '291', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 291}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-21', 'studyFirstSubmitDate': '2012-06-03', 'resultsFirstSubmitDate': '2012-06-06', 'studyFirstSubmitQcDate': '2012-06-05', 'lastUpdatePostDateStruct': {'date': '2013-05-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-04-12', 'studyFirstPostDateStruct': {'date': '2012-06-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Nausea and Vomiting', 'timeFrame': 'within 72 hours after surgery', 'description': 'A clinical investigator who is blinded to randomization assessed the incidence of postoperative nausea which defined as subjective unpleasant sensation associated with awareness of the urge to vomit and as emetic episode and vomiting'}], 'secondaryOutcomes': [{'measure': 'Pain Level', 'timeFrame': '6 to 24 hours after surgery', 'description': 'A blinded investigator asked participants to recall the most severe pain level during 6 to 24 hour after surgery using with a visual analogue scale that ranged from 0 (no pain) to 10 (worst imaginable pain).'}, {'measure': 'Wound Complication', 'timeFrame': 'within 30 days after surgery', 'description': 'Number of participants with a sinus tract communicating with the prosthesis; a pathogen was isolated by culture from tissue or fluid samples taken from the affected joint; tests revealed elevated serum erythrocyte sedimentation rate (ESR) or serum C-reactive protein (CRP) concentration with elevated synovial white blood cell (WBC) count or neutrophil percentage; or pus discharge from the affected joint was present within 30 days after total knee arthroplasty were measured.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['postoperative nausea and vomiting', 'postoperative pain'], 'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'This study was conducted to determine the efficacy of an additional preemptive, single, low-dose dexamethasone in terms of incidence and severity of postoperative nausea/vomiting (PONV), pain level, and the safety in terms of wound complications in patients managed with our antiemetic protocol based on Ramosetron following TKA.', 'detailedDescription': 'Postoperative pain and emesis can cause postoperative systemic complications and delay recovery and rehabilitation in patients following total knee arthroplasty (TKA). Furthermore, patients who suffered from severe postoperative pain and emesis tend to be dissatisfied with their surgical treatments. Although contemporary protocols to control perioperative pain and emesis after TKA have been reported to substantially reduce postoperative pain and emesis compared with traditional measures, pain and emesis after TKA remain to be a challenging issue for patients and health care providers. In our previous study, the use of Ramosetron was found to reduce postoperative emetic events, but the antiemetic effects by Ramosetron were incomplete. In search of a further antiemetic measure, we identified the use of dexamethasone as the additional measure fortifying our antiemetic protocol using Ramosetron.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of primary osteoarthritis, knee\n* Scheduled for elective total knee arthroplasty\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Refusing participate\n* Contraindication to regional anesthesia\n* Severe impairment of bowel motility\n* administration of other antiemetic drug within 24hours before surgery\n* systemic steroid within 24hours before surgery\n* history of cardiovascular \\& respiratory disease\n* renal \\& hepatic failure'}, 'identificationModule': {'nctId': 'NCT01612702', 'briefTitle': 'Efficacy and Safety of Single, Low-dose Dexamethasone in Patients After Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Use of a Single, Low-dose Dexamethasone in Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'B-1102/121-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexamethasone', 'description': 'dexamethasone 10 mg administration 1 hour before surgery', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No dexamethasone'}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Dexamethasone 10 mg intravenous administration', 'armGroupLabels': ['Dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Joint Reconstruction Center, Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'T K Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Joint Recontruction Center, Seoul National University Bundang hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tae Kyun Kim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Direcor, Joint reconstruction center, SNUBH', 'investigatorFullName': 'Tae Kyun Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}