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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?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03415958
Enrollment
49
Registered
2018-01-30
Start date
2012-03-28
Completion date
2016-10-31
Last updated
2018-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delayed Union of Fracture of Clavicle, Malunion of Fracture of Clavicle

Keywords

prospective, adolescent, displaced, clavicle, fracture, mid-shaft

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.

Interventions

None listed

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Malunion and/or non-union in this cohort3 monthsRadiographic evaluation

Secondary

MeasureTime frameDescription
Times to union (clinical and radiographic) following fracture3 monthsRadiologic evaluation

Other

MeasureTime frameDescription
Visual Analogue Scale6 weeks, 3 months, 6 months, 12 monthsa measurement instrument for subjective characteristics which cannot be directly measured
Constant Shoulder Score6 weeks, 3 months, 6 months, 12 monthsa measurement instrument for strength, range of motion, power
Disabilities of the Arm, Shoulder and Hand6 weeks, 3 months, 6 months, 12 monthsa questionnaire
Activities & Your Injury6 weeks, 3 months, 6 months, 12 monthsa questionnaire

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026