Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-02 @ 2:18 AM
Study NCT ID:
NCT04068935
Status:
COMPLETED
Last Update Posted:
2023-05-16
First Post:
2019-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Buddy Taping Compared to Splint Immobilization for Displaced Paediatric Finger Fractures
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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-15', 'studyFirstSubmitDate': '2019-08-23', 'studyFirstSubmitQcDate': '2019-08-23', 'lastUpdatePostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'secondary fracture displacement', 'timeFrame': '5 and 21 days after fracture reduction', 'description': 'X-ray controls'}], 'secondaryOutcomes': [{'measure': 'Patient comfort', 'timeFrame': '5 and 21 days after fracture reduction', 'description': 'visual analog scale (VAS): Smiley scale with a range from 1 to 10, 10 being the highest score possible, indicating that the Patient comfort was very high.'}, {'measure': 'Need for analgesic medication', 'timeFrame': '5 and 21 days after fracture reduction', 'description': 'interview with Patient and parents'}, {'measure': 'total range of Motion', 'timeFrame': '6 month after fracture reduction', 'description': 'measurement'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fracture Finger']}, 'descriptionModule': {'briefSummary': 'Fracture immobilization with Buddy taping is not inferior to Splint immobilization for non-displaced extra-articular paediatric finger fractures. However, whether the same applies for reduced finger fractures is unclear.', 'detailedDescription': 'Displaced fractures will be reduced in the paediatric ED by Emergency physicians. After fracture reduction, fracture immobilization will either be done with a Splint immobilization or a fingertaping. After 4 and 21 days, clinical and radiographic controls will take place at the Hand surgery outpatient clinic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* extraarticular displaced finger fractures of the proximal or middle phalanges\n\nExclusion Criteria:\n\n* fractures of the thumb\n* fractures that are open, instable, pathologic or multifragmented\n* multiple fractures of the Hand\n* phalangeal neck fractures\n* presentation later than 5 days after the injury'}, 'identificationModule': {'nctId': 'NCT04068935', 'briefTitle': 'Buddy Taping Compared to Splint Immobilization for Displaced Paediatric Finger Fractures', 'organization': {'class': 'OTHER', 'fullName': "University Children's Hospital, Zurich"}, 'officialTitle': 'Buddy Taping Compared to Splint Immobilizations for Reduced Paediatric Finger Fractures', 'orgStudyIdInfo': {'id': 'Buddy taping 2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Buddy taping', 'description': 'Buddy taping of the fractured finger to ist neighbouring uninjured finger.', 'interventionNames': ['Procedure: fracture immobilization after reduction of displaced finger fractures']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'splint immobilization', 'description': 'A forearm-based palmar Hand Splint in an intrinsic plus Position, enclosing all fingers without the thumb.', 'interventionNames': ['Procedure: fracture immobilization after reduction of displaced finger fractures']}], 'interventions': [{'name': 'fracture immobilization after reduction of displaced finger fractures', 'type': 'PROCEDURE', 'description': 'After closed reduction of a displaced finger fracture, fracture immobilization with either Buddy taping or Splint immobilization', 'armGroupLabels': ['Buddy taping', 'splint immobilization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8032', 'city': 'Zurich', 'country': 'Switzerland', 'facility': "University Children's Hospital Zurich", 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Michelle Seiler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "University Children's Hospital, Zurich"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "University Children's Hospital, Zurich", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}