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A Prospective Cohort of Displaced Adolescent Midshaft Clavicle Fractures

McGill University logo

McGill University

Status

Completed

Conditions

Malunion of Fracture of Clavicle
Delayed Union of Fracture of Clavicle

Study type

Observational

Funder types

Other

Identifiers

NCT03415958
10-358-PED

Details and patient eligibility

About

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.

Full 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.

Enrollment

49 patients

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

49 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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