Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT03415958
Status:
COMPLETED
Last Update Posted:
2018-01-30
First Post:
2014-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Cohort of Displaced Adolescent Midshaft Clavicle Fractures
Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Organization:
Study Overview
Official Title:
A Prospective Cohort of Displaced Adolescent Midshaft Clavicle Fractures: Are Times to Return to Activities and Functional Outcomes Reasonable for This Population?
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: