A Prospective Cohort of Displaced Adolescent Midshaft Clavicle Fractures

A Prospective Cohort of Displaced Adolescent Midshaft Clavicle Fractures: Are Times to Return to Activities and Functional Outcomes Reasonable for This Population?

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.

Study Overview

• Status: Completed
• Conditions: Malunion of Fracture of Clavicle; Delayed Union of Fracture of Clavicle

Detailed Description

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.

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.

• Study Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • McGill University Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adolescents (ages 12 to 18) who have a displaced clavicle fracture

Description

Inclusion Criteria:

• Age 12-18 years old
• The only fracture present in that upper extremity
• Individual and/or parents able to comply with follow-up

Exclusion Criteria:

• Head injury
• Prior injury, degenerative condition or congenital condition of the upper extremities
• Systemic disease that may impair healing
• Incapable of ensuring follow-up

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Open reduction internal fixation; Patients with displaced midshaft clavicle fractures will be offered operative treatment which involves open reduction and internal fixation.
Conservative care; Patients will be treated in a sling for the acute phase of two weeks with progressive physiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Malunion and/or non-union in this cohort	Radiographic evaluation	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Times to union (clinical and radiographic) following fracture	Radiologic evaluation	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale	a measurement instrument for subjective characteristics which cannot be directly measured	6 weeks, 3 months, 6 months, 12 months
Constant Shoulder Score	a measurement instrument for strength, range of motion, power	6 weeks, 3 months, 6 months, 12 months
Disabilities of the Arm, Shoulder and Hand	a questionnaire	6 weeks, 3 months, 6 months, 12 months
Activities & Your Injury	a questionnaire	6 weeks, 3 months, 6 months, 12 months

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Investigators: Principal Investigator: Edward J. Harvey, MDCM, McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2012
• Primary Completion (Actual): October 31, 2015
• Study Completion (Actual): October 31, 2016

Study Registration Dates

• First Submitted: April 3, 2014
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 30, 2018

Study Record Updates

• Last Update Posted (Actual): January 30, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: adolescent; fracture; prospective; clavicle; displaced; mid-shaft
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Malunited
• Other Study ID Numbers: 10-358-PED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make IPD available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No