Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT00872105
Status:
COMPLETED
Last Update Posted:
2019-11-27
First Post:
2009-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-25', 'studyFirstSubmitDate': '2009-03-30', 'studyFirstSubmitQcDate': '2009-03-30', 'lastUpdatePostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measurement will be patient DASH (Disabilities of the Arm, Shoulder and Hand Instrument) scores. The DASH is a patient-oriented, limb-specific, functional measurement questionnaire.', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': "The secondary outcome measurement patients' functional shoulder scores as defined by Constant's Shoulder Score (i.e. pain, activities of daily living, range of motion and power).", 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['clavicle', 'fractures', 'distal'], 'conditions': ['Clavicle Fracture', 'Fractures']}, 'descriptionModule': {'briefSummary': 'This is a multicentre randomized clinical trial prospectively comparing operative treatment versus conservative (nonoperative) care in the management of displaced distal (Type II) clavicle fractures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women aged 16 to 60 years of age\n* Completely displaced (no cortical contact), closed fracture of the distal 3rd of the clavicle (Type II) confirmed by radiograph\n* Fractures within 28 days post injury\n* Provision of informed consent\n\nExclusion Criteria:\n\n* Pathological fractures\n* Non-displaced (cortical contact) distal clavicle fractures\n* Open clavicle fractures\n* Presence of vascular injury\n* Fractures more than 28 days post-injury\n* Limited life expectancy due to significant medical co-morbidity\n* Medical contraindication to surgery\n* Inability to comply with rehabilitation or form completion\n* Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)'}, 'identificationModule': {'nctId': 'NCT00872105', 'briefTitle': 'Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'A Multicentre, Randomized Trial of Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle', 'orgStudyIdInfo': {'id': 'Distal Clavicle Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Non-operative treatment', 'description': 'The first treatment strategy will involve conservative (nonoperative) management of the clavicle fracture.', 'interventionNames': ['Procedure: Non-operative Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Operative treatment', 'description': 'The second treatment strategy will involve operative fixation (i.e. ORIF) of the fracture with a plate and screws.', 'interventionNames': ['Procedure: Operative Treatment']}], 'interventions': [{'name': 'Non-operative Treatment', 'type': 'PROCEDURE', 'description': 'Standard protocol for conservative treatment will consist of the implementation of a sling, for clavicular support and patient comfort. Pendulum or gentle Range of Motion (ROM) shoulder exercises may be implemented at any time as dictated by the attending surgeon.', 'armGroupLabels': ['Non-operative treatment']}, {'name': 'Operative Treatment', 'type': 'PROCEDURE', 'description': 'The operating surgeon will determine the positioning of the patient for surgery. ORIF of the distal clavicle fracture will be carried out as follows:\n\nAnatomic reduction of the fracture Definitive fixation with a contoured clavicle plate and screws; a AO hook plate; a 3.5 LCDC, reconstruction, or compression plate is acceptable; a 1/3 tubular plate is not acceptable Use of bone graft is optional (iliac crest bone autograft)', 'armGroupLabels': ['Operative treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5C 1R6', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Jeremy A Hall, MD, FRCS(C)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unity Health Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fraser Health', 'class': 'OTHER'}, {'name': 'University of British Columbia', 'class': 'OTHER'}, {'name': 'London Health Sciences Centre', 'class': 'OTHER'}, {'name': 'University of Calgary', 'class': 'OTHER'}, {'name': 'Nova Scotia Health Authority', 'class': 'OTHER'}, {'name': 'Winnipeg Regional Health Authority', 'class': 'OTHER'}, {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, {'name': 'The Ottawa Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}