Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT05012969
Status:
COMPLETED
Last Update Posted:
2022-12-08
First Post:
2015-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Efficacy of Use of a Bandage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006617', 'term': 'Hip Dislocation'}], 'ancestors': [{'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-07', 'studyFirstSubmitDate': '2015-11-19', 'studyFirstSubmitQcDate': '2021-08-12', 'lastUpdatePostDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of dislocations', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Hip function', 'timeFrame': '12 weeks', 'description': 'Oxford Hip Score, scores running from 0 to 48 with 48 being the best outcome'}, {'measure': 'Helat-related quality of life', 'timeFrame': '12 weeks', 'description': 'SF-36, a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability'}, {'measure': 'Patient satisfaction', 'timeFrame': '12 weeks', 'description': 'questions to patients'}, {'measure': 'Safety, wear and durability of bandage', 'timeFrame': '12 weeks', 'description': 'Questionnaire to physiotherapists'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hip Dislocation']}, 'descriptionModule': {'briefSummary': 'This trial investigates the effectiveness of using a bandage after dislocation of the hip after total hip arthroplasty.\n\nPatients with a dislocated hip after total hip arthroplasty coming to the emergency department to have the hip relocated will be asked to participate in the trial. The patients will be randomised to either a bandage that reduces flexion, adduction and internal rotation of the hip or no bandage.', 'detailedDescription': "This trial investigates the effectiveness of using a bandage after dislocation of the hip after total hip arthroplasty.\n\nPatients with a dislocated hip after total hip arthroplasty coming to the emergency department to have the hip relocated will be asked to participate in the trial. The patients will be randomised to either a bandage that reduces flexion, adduction and internal rotation of the hip or no bandage. Patients in the intervention group will use the bandage for 12 weeks and patients in the control group will receive the normal treatment which is information by a physiotherapist on movement restrictions.\n\n50 patients will be allocated in the intervention group and 50 patients will be allocated to the control group.\n\nWe will investigate:\n\n1. Whether there is a difference in number of dislocations between the two groups in the project period (12 weeks).\n2. Patients' hip function, quality of life and satisfaction with the treatment in the two groups\n3. The safety, wear and durability of the bandage after 12 weeks of use"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has had at least one previous hip dislocation after total hip arthroplasty\n\nExclusion Criteria:\n\n* Dislocation in other directions than posterior/superior\n* Loose prosthesis\n* wounds in the area of skin that is in contact with the bandage'}, 'identificationModule': {'nctId': 'NCT05012969', 'briefTitle': 'Investigation of Efficacy of Use of a Bandage', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Investigation of Efficacy of Use of a Bandage to Prevent Hip Dislocation After Total Hip Arthroplasty in Patients With Previous Dislocation', 'orgStudyIdInfo': {'id': 'HipStop'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'HipStop bandage for 12 weeks to prevent dislocation of the hip', 'interventionNames': ['Device: Hipstop bandage']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'normal procedure after dislocation of hip which is information on movement restrictions'}], 'interventions': [{'name': 'Hipstop bandage', 'type': 'DEVICE', 'description': '12 weeks use of a bandage to prevent hip dislocations in patients with previous dislocations', 'armGroupLabels': ['intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7500', 'city': 'Holstebro', 'country': 'Denmark', 'facility': 'Holstebro Regional Hospital', 'geoPoint': {'lat': 56.36009, 'lon': 8.61607}}, {'zip': '8800', 'city': 'Viborg', 'country': 'Denmark', 'facility': 'Viborg Regional Hospital', 'geoPoint': {'lat': 56.45319, 'lon': 9.40201}}], 'overallOfficials': [{'name': 'Inger Mechlenburg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aarhus'}, {'name': 'Maiken Stilling, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aarhus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}