A Prospective Cohort of Displaced Adolescent Midshaft Clavicle Fractures

Delayed Union of Fracture of Clavicle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03415958
• Other study ID #: 10-358-PED
• Status: Completed
• Phase: N/A
• First received: April 3, 2014
• Last updated: January 23, 2018
• Start date: March 28, 2012
• Est. completion date: October 31, 2016

Study information

• Verified date: January 2018
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: October 31, 2016
• Est. primary completion date: October 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Delayed Union of Fracture of Clavicle
• Fractures, Bone
• Fractures, Ununited
• Malunion of Fracture of Clavicle

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

References & Publications (11)

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. — View 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. — View Citation

Kocher MS, Waters PM, Micheli LJ. Upper extremity injuries in the paediatric athlete. Sports Med. 2000 Aug;30(2):117-35. Review. — View 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. — View 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. — View 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. — View Citation

McKee MD, Wild LM, Schemitsch EH. Midshaft malunions of the clavicle. J Bone Joint Surg Am. 2003 May;85-A(5):790-7. — View 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. — View Citation

Taylor DC, Krasinski KL. Adolescent shoulder injuries: consensus and controversies. J Bone Joint Surg Am. 2009 Feb;91(2):462-73. Review. — View 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. — View 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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visual Analogue Scale	a measurement instrument for subjective characteristics which cannot be directly measured	6 weeks, 3 months, 6 months, 12 months
Other	Constant Shoulder Score	a measurement instrument for strength, range of motion, power	6 weeks, 3 months, 6 months, 12 months
Other	Disabilities of the Arm, Shoulder and Hand	a questionnaire	6 weeks, 3 months, 6 months, 12 months
Other	Activities & Your Injury	a questionnaire	6 weeks, 3 months, 6 months, 12 months
Primary	Malunion and/or non-union in this cohort	Radiographic evaluation	3 months
Secondary	Times to union (clinical and radiographic) following fracture	Radiologic evaluation	3 months