Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-02-26 @ 7:24 PM
Study NCT ID:
NCT02052466
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2014-01-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prediction of Development of Scapular Notching Following Reverse Total Shoulder Arthroplasty
Sponsor:
Eric Ricchetti
Organization:
Study Overview
Official Title:
Prediction of Development of Scapular Notching Based on Glenosphere Positioning, Scapular Morphology, and Simulated Impingement-free Motion Using Three-dimensional Computed Tomography Analysis
Status:
COMPLETED
Status Verified Date:
2017-05
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:
The hypothesis is that computer simulated bony impingement of the bone surrounding the spherical glenoid implant (the glenosphere) along the scapular neck on three-dimensional (3-D) computed tomography (CT) imaging analysis is predictive of the location of clinical scapular notching that develops following reverse total shoulder arthroplasty (TSA).
Detailed Description:
The Specific Aims are:
* Determine the relationship between lateral glenoid offset and the development of scapular notching following reverse TSA
* Determine the ability of 3-D preoperative planning tools to define areas of scapular bony impingement on kinematic simulated shoulder range of motion that predict the development of scapular notching
* Compare the precision and accuracy of plain radiographs (2-D) versus CT (3-D) for measurement of scapular notching and postoperative implant position following reverse TSA (2-D versus 3-D)
* Determine the implant and anatomic factors that best correlate with clinical outcome following reverse TSA by retrospective analysis
* Determine the relationship between lateral glenoid offset and the development of scapular notching following reverse TSA
* Determine the ability of 3-D preoperative planning tools to define areas of scapular bony impingement on kinematic simulated shoulder range of motion that predict the development of scapular notching
* Compare the precision and accuracy of plain radiographs (2-D) versus CT (3-D) for measurement of scapular notching and postoperative implant position following reverse TSA (2-D versus 3-D)
* Determine the implant and anatomic factors that best correlate with clinical outcome following reverse TSA by retrospective analysis
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?: