Clinical trial NCT03415958: A Prospective Cohort of Displaced Adolescent Midshaft Clavicle Fractures
Official title: A Prospective Cohort of Displaced Adolescent Midshaft Clavicle Fractures: Are Times to Return to Activities and Functional Outcomes Reasonable for This Population?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malunion of Fracture of Clavicle
Delayed Union of Fracture of Clavicle
Keywords: prospective
adolescent
displaced
clavicle
fracture
mid-shaft
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 49
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents (ages 12 to 18) who have a displaced clavicle fracture

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Malunion and/or non-union in this cohort
timeFrame: 3 months
Secondary outcomes:
measure: Times to union (clinical and radiographic) following fracture
timeFrame: 3 months
Other outcomes:
measure: Visual Analogue Scale
timeFrame: 6 weeks, 3 months, 6 months, 12 months
measure: Constant Shoulder Score
timeFrame: 6 weeks, 3 months, 6 months, 12 months
measure: Disabilities of the Arm, Shoulder and Hand
timeFrame: 6 weeks, 3 months, 6 months, 12 months
measure: Activities & Your Injury
timeFrame: 6 weeks, 3 months, 6 months, 12 months
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Edward J. Harvey, MDCM
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.