Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05867355
Status:
RECRUITING
Last Update Posted:
2023-05-22
First Post:
2023-05-04
Brief Title:
Surgically Treated Displaced Mid-diaphyseal Clavicle Fractures
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
A Multi-Centre Prospective Cohort Study of Surgically Treated Displaced Mid-diaphyseal Clavicle Fractures
Status:
RECRUITING
Status Verified Date:
2023-05
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:
This prospective multi-centre study aims to determine clinical radiographic and patient-reported outcomes PROMs following surgical fixation of displaced mid-diaphyseal clavicle fractures and to compare implant removal rates between techniques within 2-years of the procedure
Detailed Description:
Given the substantially lower implant removal rate in combination with a high union rate with the dual mini-fragment technique we do not believe there is clinical equipoise required for a randomized clinical trial
This study is a multi-centre prospective cohort study 11 sites confirmed to date of all operatively treated clavicle fractures in order to objectively evaluate all current surgical techniques used across Canada This pragmatic approach will allow us to observe surgical decision-making rationale for implant removal and report on clinical radiographic and patient-reported outcomes for all techniques over a 2-year follow-up timeframe for the first time
All enrolled patients will be encouraged to begin immediate range of motion as tolerated and weightbearing as tolerated post-operatively This will be assessed at each follow-up and any reason for delayed motion or weightbearing will be reported
This study is a multi-centre prospective cohort study 11 sites confirmed to date of all operatively treated clavicle fractures in order to objectively evaluate all current surgical techniques used across Canada This pragmatic approach will allow us to observe surgical decision-making rationale for implant removal and report on clinical radiographic and patient-reported outcomes for all techniques over a 2-year follow-up timeframe for the first time
All enrolled patients will be encouraged to begin immediate range of motion as tolerated and weightbearing as tolerated post-operatively This will be assessed at each follow-up and any reason for delayed motion or weightbearing will be reported
Study Oversight
Has Oversight DMC:
None
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?:
None