Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-04-21 @ 7:28 PM
Study NCT ID:
NCT03328650
Status:
RECRUITING
Last Update Posted:
2025-04-01
First Post:
2017-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcomes of the ALPS Proximal Humerus Plating System
Sponsor:
Vanderbilt University Medical Center
Organization:
Study Overview
Official Title:
Clinical Outcomes of the ALPS Proximal Humerus Plating System
Status:
RECRUITING
Status Verified Date:
2025-03
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:
ALPS PHP
Brief Summary:
The purpose of this study is to document the performance and clinical outcomes of the A.L.P.S® Proximal Humerus Plating System.
Specific Aims:
* Conduct physical assessments measuring shoulder strength and range of motion, physician assessment of radiographs
* Obtain patient-reported outcomes regarding pain level, function capabilities, and work/leisure restrictions
* Document revisions, complications, and adverse events
Specific Aims:
* Conduct physical assessments measuring shoulder strength and range of motion, physician assessment of radiographs
* Obtain patient-reported outcomes regarding pain level, function capabilities, and work/leisure restrictions
* Document revisions, complications, and adverse events
Detailed Description:
The purpose of this study is to document the performance and clinical outcomes of the A.L.P.S® Proximal Humerus Plating System.
Specific Aims:
* Conduct physical assessments measuring shoulder strength and range of motion, physician assessment of radiographs
* Obtain patient-reported outcomes regarding pain level, function capabilities, and work/leisure restrictions
* Document revisions, complications, and adverse events
Specific Aims:
* Conduct physical assessments measuring shoulder strength and range of motion, physician assessment of radiographs
* Obtain patient-reported outcomes regarding pain level, function capabilities, and work/leisure restrictions
* Document revisions, complications, and adverse events
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?:
False
Is an FDA AA801 Violation?: