Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-31 @ 10:03 PM
Study NCT ID:
NCT01975467
Status:
TERMINATED
Last Update Posted:
2016-12-28
First Post:
2013-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post Treatment Comparison Intramedullary Nail vs. Nonoperative Treatment
Sponsor:
Sonoma Orthopedic Products, Inc.
Organization:
Study Overview
Official Title:
CLAVICLE FRACTURE OUTCOMES: 1-3 YEAR FOLLOW UP OF DISPLACED MIDSHAFT FRACTURES TREATED WITH INTRAMEDULARY NAIL vs. NONOPERATIVE TREATMENT
Status:
TERMINATED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low Enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this post-market clinical study is to compare one to three year post treatment results, range of motion, strength, patient related functional outcomes and patient satisfaction, of internal fixation using the Sonoma Orthopedic Products CRx™ as compared to nonoperative management (e.g. sling) of similar displaced midshaft clavicle fractures.
Detailed Description:
None
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?: