Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-26 @ 12:09 PM
Study NCT ID:
NCT00871468
Status:
UNKNOWN
Last Update Posted:
2017-10-13
First Post:
2009-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plating Clavicle Fractures
Sponsor:
United States Army Institute of Surgical Research
Organization:
Study Overview
Official Title:
Does Anterior-Inferior Clavicle Plating Have a Lower Rate of Soft Tissue Irritation Compared to Superior Plating? A Prospective Randomized Trial
Status:
UNKNOWN
Status Verified Date:
2016-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The anterior-inferior clavicle plate position will have a lower rate of soft tissue irritation that limits activity and/or requires hardware removal compared to superior plate position.
Detailed Description:
Compare the rates of soft-tissue irritation with two different methods of plating for clavicle fractures. Patients will be randomized to anterior-inferior or superior plating. Validated shoulder scoring systems will be used to assess outcome. Specific follow-up questions will address the patient's ability to wear his/her uniform, body armor, ruck sack, and other shoulder-borne equipment over the surgical site.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: