Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06320925
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-13
Brief Title:
SportsPro Post-Market Clinical Follow Up Study
Sponsor:
Stryker Endoscopy
Organization:
Stryker Endoscopy
Study Overview
Official Title:
A Retrospective Multi-Center Post-Market Clinical Follow-Up Study of Stryker Class IIb Implants
Status:
RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
Retrospective multi-center chart review only to include data that is part of the surgeons standard practice
Detailed Description:
The purpose of this study is to leverage standard of care data to provide further characterization of clinical outcomes following shoulder hip and knee joint surgeries
Primary Objective To describe clinical outcomes of the Stryker Device in the shoulder hip and knee joints 6 months after surgical intervention
Secondary Objective To describe clinical outcomes of the Stryker Device in the shoulder hip and knee joints 3 months after surgical intervention
Safety Objective To describe safety of the Stryker implants in the shoulder hip and knee joints 6 months after intervention
Primary Objective To describe clinical outcomes of the Stryker Device in the shoulder hip and knee joints 6 months after surgical intervention
Secondary Objective To describe clinical outcomes of the Stryker Device in the shoulder hip and knee joints 3 months after surgical intervention
Safety Objective To describe safety of the Stryker implants in the shoulder hip and knee joints 6 months after intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None