Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT03415958
Status:
COMPLETED
Last Update Posted:
2018-01-30
First Post:
2014-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Cohort of Displaced Adolescent Midshaft Clavicle Fractures
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2014-04-03', 'studyFirstSubmitQcDate': '2018-01-23', 'lastUpdatePostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Visual Analogue Scale', 'timeFrame': '6 weeks, 3 months, 6 months, 12 months', 'description': 'a measurement instrument for subjective characteristics which cannot be directly measured'}, {'measure': 'Constant Shoulder Score', 'timeFrame': '6 weeks, 3 months, 6 months, 12 months', 'description': 'a measurement instrument for strength, range of motion, power'}, {'measure': 'Disabilities of the Arm, Shoulder and Hand', 'timeFrame': '6 weeks, 3 months, 6 months, 12 months', 'description': 'a questionnaire'}, {'measure': 'Activities & Your Injury', 'timeFrame': '6 weeks, 3 months, 6 months, 12 months', 'description': 'a questionnaire'}], 'primaryOutcomes': [{'measure': 'Malunion and/or non-union in this cohort', 'timeFrame': '3 months', 'description': 'Radiographic evaluation'}], 'secondaryOutcomes': [{'measure': 'Times to union (clinical and radiographic) following fracture', 'timeFrame': '3 months', 'description': 'Radiologic evaluation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prospective', 'adolescent', 'displaced', 'clavicle', 'fracture', 'mid-shaft'], 'conditions': ['Malunion of Fracture of Clavicle', 'Delayed Union of Fracture of Clavicle']}, 'referencesModule': {'references': [{'pmid': '20502227', 'type': 'BACKGROUND', 'citation': 'Vander Have KL, Perdue AM, Caird MS, Farley FA. Operative versus nonoperative treatment of midshaft clavicle fractures in adolescents. J Pediatr Orthop. 2010 Jun;30(4):307-12. doi: 10.1097/BPO.0b013e3181db3227.'}, {'pmid': '19181993', 'type': 'BACKGROUND', 'citation': 'Taylor DC, Krasinski KL. Adolescent shoulder injuries: consensus and controversies. J Bone Joint Surg Am. 2009 Feb;91(2):462-73. No abstract available.'}, {'pmid': '10966151', 'type': 'BACKGROUND', 'citation': 'Kocher MS, Waters PM, Micheli LJ. Upper extremity injuries in the paediatric athlete. Sports Med. 2000 Aug;30(2):117-35. doi: 10.2165/00007256-200030020-00005.'}, {'pmid': '9250733', 'type': 'BACKGROUND', 'citation': 'Hill JM, McGuire MH, Crosby LA. Closed treatment of displaced middle-third fractures of the clavicle gives poor results. J Bone Joint Surg Br. 1997 Jul;79(4):537-9. doi: 10.1302/0301-620x.79b4.7529.'}, {'pmid': '12728026', 'type': 'BACKGROUND', 'citation': 'McKee MD, Wild LM, Schemitsch EH. Midshaft malunions of the clavicle. J Bone Joint Surg Am. 2003 May;85(5):790-7. doi: 10.2106/00004623-200305000-00003.'}, {'pmid': '16391247', 'type': 'BACKGROUND', 'citation': 'McKee MD, Pedersen EM, Jones C, Stephen DJ, Kreder HJ, Schemitsch EH, Wild LM, Potter J. Deficits following nonoperative treatment of displaced midshaft clavicular fractures. J Bone Joint Surg Am. 2006 Jan;88(1):35-40. doi: 10.2106/JBJS.D.02795.'}, {'pmid': '16015232', 'type': 'BACKGROUND', 'citation': 'Ledger M, Leeks N, Ackland T, Wang A. Short malunions of the clavicle: an anatomic and functional study. J Shoulder Elbow Surg. 2005 Jul-Aug;14(4):349-54. doi: 10.1016/j.jse.2004.09.011.'}, {'pmid': '19934713', 'type': 'BACKGROUND', 'citation': 'McGraw MA, Mehlman CT, Lindsell CJ, Kirby CL. Postnatal growth of the clavicle: birth to 18 years of age. J Pediatr Orthop. 2009 Dec;29(8):937-43. doi: 10.1097/BPO.0b013e3181c11992.'}, {'pmid': '19934697', 'type': 'BACKGROUND', 'citation': 'Mehlman CT, Yihua G, Bochang C, Zhigang W. Operative treatment of completely displaced clavicle shaft fractures in children. J Pediatr Orthop. 2009 Dec;29(8):851-5. doi: 10.1097/BPO.0b013e3181c29c9c.'}, {'pmid': '16056089', 'type': 'BACKGROUND', 'citation': 'Zlowodzki M, Zelle BA, Cole PA, Jeray K, McKee MD; Evidence-Based Orthopaedic Trauma Working Group. Treatment of acute midshaft clavicle fractures: systematic review of 2144 fractures: on behalf of the Evidence-Based Orthopaedic Trauma Working Group. J Orthop Trauma. 2005 Aug;19(7):504-7. doi: 10.1097/01.bot.0000172287.44278.ef.'}, {'pmid': '17200303', 'type': 'BACKGROUND', 'citation': 'Canadian Orthopaedic Trauma Society. Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. A multicenter, randomized clinical trial. J Bone Joint Surg Am. 2007 Jan;89(1):1-10. doi: 10.2106/JBJS.F.00020.'}]}, 'descriptionModule': {'briefSummary': 'Outcomes for displaced midshaft clavicle fractures in adolescents are not defined. The current method of treatment for these fractures is non-operative management. There is recent Level 1 evidence in the adult literature to suggest that outcomes are superior when these fractures are managed surgically with open reduction and internal fixation.', 'detailedDescription': 'The study is a prospective observational cohort design of the natural history of adolescent clavicle fractures treated at the McGill University Health Centre. Surgeon choice will dictate treatment. There is no difference from the current normal therapy choice of each individual surgeon. Patients will be offered either operative or conservative management.\n\nOperative Treatment: Patients with displaced midshaft clavicle fractures will be offered operative treatment which involves open reduction and internal fixation with a plate. This is the standard treatment for completely displaced fractures in the adult population at our Institution based on Level 1 evidence.\n\nConservative care: Patients will be treated in a sling for the acute phase of two weeks with progressive physiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adolescents (ages 12 to 18) who have a displaced clavicle fracture', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 12-18 years old\n* The only fracture present in that upper extremity\n* Individual and/or parents able to comply with follow-up\n\nExclusion Criteria:\n\n* Head injury\n* Prior injury, degenerative condition or congenital condition of the upper extremities\n* Systemic disease that may impair healing\n* Incapable of ensuring follow-up'}, 'identificationModule': {'nctId': 'NCT03415958', 'briefTitle': 'A Prospective Cohort of Displaced Adolescent Midshaft Clavicle Fractures', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'A Prospective Cohort of Displaced Adolescent Midshaft Clavicle Fractures: Are Times to Return to Activities and Functional Outcomes Reasonable for This Population?', 'orgStudyIdInfo': {'id': '10-358-PED'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Open reduction internal fixation', 'description': 'Patients with displaced midshaft clavicle fractures will be offered operative treatment which involves open reduction and internal fixation.'}, {'label': 'Conservative care', 'description': 'Patients will be treated in a sling for the acute phase of two weeks with progressive physiotherapy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Health Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Edward J. Harvey, MDCM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make IPD available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopaedic Surgeon', 'investigatorFullName': 'Edward Harvey', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}