Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-05 @ 6:25 PM
Study NCT ID:
NCT03789266
Status:
UNKNOWN
Last Update Posted:
2020-06-26
First Post:
2018-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drains Ablation Post Total Hip Arthroplasty : Search for the Least Painful Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'patient will not know which technique will be used for drain ablation'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-25', 'studyFirstSubmitDate': '2018-07-24', 'studyFirstSubmitQcDate': '2018-12-27', 'lastUpdatePostDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the pain felt by the patients at the time of the removal of the drain, using the pain visual analogue scale', 'timeFrame': '20 minutes', 'description': 'pain will be measured using a visual analogic scale from 0 (for no pain) to 10 (fo maximum pain)'}], 'secondaryOutcomes': [{'measure': 'Presence of haematoma after ablation', 'timeFrame': 'Day 2 post ablation', 'description': 'Presence or absence of haematoma will be visually checked'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Total Hip Arthroplasty', 'Drain Insertion Site']}, 'descriptionModule': {'briefSummary': 'Comparison of ablation technique of drains'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients admitted to the orthopedic surgery department for surgery for a total hip arthroplasty\n2. Signed inform consent form\n\nExclusion Criteria:\n\n1. Drain in non-aspirating mode at the time of medical ablation prescription\n2. Administration of analgesic III in the 12 hours preceding the inclusion'}, 'identificationModule': {'nctId': 'NCT03789266', 'acronym': 'TADDA', 'briefTitle': 'Drains Ablation Post Total Hip Arthroplasty : Search for the Least Painful Technique', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Drains Ablation Post Total Hip Arthroplasty : Search for the Least Painful Technique', 'orgStudyIdInfo': {'id': '2016/382/HP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drain ablation - Non Aspiration mode', 'description': 'Drain ablation will be done in non Aspiration mode', 'interventionNames': ['Procedure: drain ablation']}, {'type': 'OTHER', 'label': 'Drain ablation - Aspiration mode', 'description': 'Drain ablation will be done in Aspiration mode', 'interventionNames': ['Procedure: drain ablation']}], 'interventions': [{'name': 'drain ablation', 'type': 'PROCEDURE', 'description': 'drain ablation will be done in Aspiration mode or in non Aspiration mode', 'armGroupLabels': ['Drain ablation - Aspiration mode', 'Drain ablation - Non Aspiration mode']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mylène BONNAIRE', 'role': 'CONTACT'}], 'facility': 'Rouen University Hospital', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'centralContacts': [{'name': 'Mylène BONNAIRE, Ms', 'role': 'CONTACT', 'email': 'mylene.bonnaire@chu-rouen.Fr', 'phone': '+3323288', 'phoneExt': '8265'}, {'name': 'Julien BLOT', 'role': 'CONTACT', 'email': 'julien.blot@chu-rouen.fr', 'phone': '+3323288', 'phoneExt': '8265'}], 'overallOfficials': [{'name': 'Mylène BONNAIRE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Rouen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}