Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
Study NCT ID:
NCT01936259
Status:
COMPLETED
Last Update Posted:
2020-01-13
First Post:
2013-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comprehensive Shoulder System Nano IDE
Sponsor:
Zimmer Biomet
Organization:
Study Overview
Official Title:
A Study of the Comprehensive Shoulder System With Nano Humeral Component in Total Shoulder Arthroplasty
Status:
COMPLETED
Status Verified Date:
2020-01
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:
Nano
Brief Summary:
The purpose of this clinical study is to determine the safety and efficacy of the Comprehensive® Shoulder System with Nano Humeral Component in Total Shoulder Arthroplasty (TSA).
Detailed Description:
The purpose of this clinical investigation is to establish the safety and efficacy of the Comprehensive® Shoulder System with Nano Humeral Component in Total Shoulder Arthroplasty. Safety and efficacy of the device will be measured by collection and analysis of the following data at the two-year or greater time point (22 months post-operative or longer):
1. American Shoulder and Elbow Surgeons (ASES) Score
2. Single Assessment Numeric Evaluation (SANE)
3. Constant Score
4. Radiographic assessment of osteolysis, radiolucencies, migration, and subsidence
5. Comparison of overall adverse event rates including rates of removal/revision and other serious adverse events.
1. American Shoulder and Elbow Surgeons (ASES) Score
2. Single Assessment Numeric Evaluation (SANE)
3. Constant Score
4. Radiographic assessment of osteolysis, radiolucencies, migration, and subsidence
5. Comparison of overall adverse event rates including rates of removal/revision and other serious adverse events.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| G110207 | OTHER | FDA | View |