A Prospective Cohort of Displaced Adolescent Midshaft Clavicle Fractures
NCT ID: NCT03415958
Last Updated: 2018-01-30
Study Results
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Basic Information
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COMPLETED
49 participants
OBSERVATIONAL
2012-03-28
2016-10-31
Brief Summary
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Detailed Description
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Operative 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.
Conservative care: Patients will be treated in a sling for the acute phase of two weeks with progressive physiotherapy.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Open reduction internal fixation
Patients with displaced midshaft clavicle fractures will be offered operative treatment which involves open reduction and internal fixation.
No interventions assigned to this group
Conservative care
Patients will be treated in a sling for the acute phase of two weeks with progressive physiotherapy.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* The only fracture present in that upper extremity
* Individual and/or parents able to comply with follow-up
Exclusion Criteria
* Prior injury, degenerative condition or congenital condition of the upper extremities
* Systemic disease that may impair healing
* Incapable of ensuring follow-up
12 Years
18 Years
ALL
No
Sponsors
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McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
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Edward Harvey
Orthopaedic Surgeon
Principal Investigators
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Edward J. Harvey, MDCM
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Locations
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McGill University Health Centre
Montreal, Quebec, Canada
Countries
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References
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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.
Taylor DC, Krasinski KL. Adolescent shoulder injuries: consensus and controversies. J Bone Joint Surg Am. 2009 Feb;91(2):462-73. No abstract available.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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10-358-PED
Identifier Type: -
Identifier Source: org_study_id
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