Ignite Creation Date:
2025-12-25 @ 4:45 AM
Ignite Modification Date:
2025-12-26 @ 3:47 AM
Study NCT ID:
NCT06276218
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2024-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Self - Adjustable Clavicular Brace Versus Standard Clavicular Brace for Treatment of Mid Shaft Clavicle Fracture: A Randomized Controlled Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-18', 'studyFirstSubmitDate': '2024-02-18', 'studyFirstSubmitQcDate': '2024-02-18', 'lastUpdatePostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DASH', 'timeFrame': '1, 2, 4, 6, 12 week', 'description': 'DISABILITIES OF THE ARM, SHOULDER AND HAND'}], 'secondaryOutcomes': [{'measure': 'Pain, analgesic usage, radiographic outcomes, time to union, and patient satisfaction', 'timeFrame': '1, 2, 4, 6, 12 week', 'description': 'Pain, analgesic usage, radiographic outcomes, time to union, and patient satisfaction'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clavicle fracture, treatment of clavicle fracture, clavicular brace, figure of eight bandage'], 'conditions': ['Clavicle Fracture']}, 'descriptionModule': {'briefSummary': 'A randomized control trial was conducted to compare the outcomes of conservative management for closed midshaft clavicular fractures using self-adjustable clavicular brace and standard clavicular brace.', 'detailedDescription': 'Ten patients aged 18-75 years with midshaft clavicle fractures were enrolled in the study during February 2022 to February 2023. 6 patients were managed with standard clavicular brace and 4 patients with self-adjustable clavicular brace. All patients were scheduled for follow-up appointments at 1 week, 2 weeks, 4 weeks, 6 weeks and 12 weeks. Results were assessed based on clinical, functional and radiographic outcomes using the DASH questionnaire, pain, measured by VAS, analgesic usage, displacement, shortening, time to union, and patient satisfaction,'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with aged between 18 - 75 years old\n* Closed isolated fracture midshaft of clavicle within 9 days after the injury date\n\nExclusion Criteria:\n\n* After bracing, fracture displacement and/or shortening \\> 2 cm or fracture comminution \\> 3 fragments\n* Segmental fracture\n* Open fracture\n* Impending open fracture (soft tissue compromise/skin lesion)\n* Ipsilateral upper extremities fracture which disturbs clavicular bracing\n* Floating shoulder which surgical treatment is indicated.\n* Patients with other injuries (e.g. head injury, chest and abdomen injury) which interrupted clavicular bracing\n* Pathologic fracture\n* Patient has limitation for clavicular brace application\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT06276218', 'briefTitle': 'Efficacy of Self - Adjustable Clavicular Brace Versus Standard Clavicular Brace for Treatment of Mid Shaft Clavicle Fracture: A Randomized Controlled Study', 'organization': {'class': 'OTHER', 'fullName': 'Prince of Songkla University'}, 'officialTitle': 'Efficacy of Self - Adjustable Clavicular Brace Versus Standard Clavicular Brace for Treatment of Mid Shaft Clavicle Fracture: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'PSU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'self-adjustable clavicular brace', 'interventionNames': ['Device: Clavicular brace']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard clavicular brace', 'interventionNames': ['Device: Clavicular brace']}], 'interventions': [{'name': 'Clavicular brace', 'type': 'DEVICE', 'description': 'Clavicular brace for conservative treatment of closed midshaft clavicular fractures', 'armGroupLabels': ['self-adjustable clavicular brace', 'standard clavicular brace']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90110', 'city': 'Songkhla', 'state': 'Hatyai', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Thanachai Klongsangsorn', 'role': 'CONTACT', 'email': 'poom_thanachai@hotmail.com', 'phone': '+66991964733'}], 'facility': 'Prince of Songkla University', 'geoPoint': {'lat': 7.19882, 'lon': 100.5951}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prince of Songkla University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Thanachai Klongsangsorn', 'investigatorAffiliation': 'Prince of Songkla University'}}}}