Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-02-22 @ 7:04 AM
Study NCT ID:
NCT02983292
Status:
COMPLETED
Last Update Posted:
2024-11-04
First Post:
2016-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PyroTITAN Humeral Resurfacing Arthroplasty (HRA)
Sponsor:
Smith & Nephew, Inc.
Organization:
Study Overview
Official Title:
A Clinical and Radiological Study to Evaluate the Safety and Efficacy of the PyroTITAN Humeral Resurfacing Arthroplasty (HRA) Device in a New Cohort of Patients After Product Re-Release
Status:
COMPLETED
Status Verified Date:
2024-06
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:
HRA
Brief Summary:
The study is designed as a single center, post-market, non-randomized, open-label, observational clinical study with retrospective and prospective enrollment to evaluate the 2-year post implantation survivorship of the PyroTITAN™ HRA device following the implementation of a new proof test to identify and eliminate devices with sub-standard mechanical integrity.
Detailed Description:
The study is designed as a single center, post-market, non-randomized, open-label, observational clinical study with retrospective and prospective enrollment to evaluate the 2-year post implantation survivorship of the PyroTITAN™ HRA device following the implementation of a new proof test to identify and eliminate devices with sub-standard mechanical integrity. The results will be compared to data collected in a prior study conducted before implementing the new proof test. The PyroTITAN™ HRA Shoulder prosthesis device configuration will include humeral resurfacing CAP without cement. Patients will be selected retrospectively and prospectively for recruitment into the study based upon the normally accepted criteria for primary shoulder resurfacing arthroplasty.
137 subjects with PyroTITAN™ HRA Shoulder prosthesis arthroplasties will be implanted and followed for up to 60 months.
137 subjects with PyroTITAN™ HRA Shoulder prosthesis arthroplasties will be implanted and followed for up to 60 months.
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?: