A Prospective Cohort of Displaced Adolescent Midshaft Clavicle Fractures

Completed

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

• Registration Number: NCT03415958
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Study Timeline

• Study Start: 2012-03-28
• Study First Submitted: 2014-04-03
• Primary Completion: 2015-10-31
• Study Completion: 2016-10-31
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-23
• Last Update Submitted: 2018-01-23
• Study First Posted: 2018-01-30
• Last Update Posted: 2018-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Malunion and/or non-union in this cohort	3 months	Radiographic evaluation

Secondary Outcome Measures

Name	Time	Method
Times to union (clinical and radiographic) following fracture	3 months	Radiologic evaluation

Trial Locations

Locations (1)

McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada