Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-01-04 @ 8:52 PM
Study NCT ID:
NCT03914703
Status:
COMPLETED
Last Update Posted:
2025-07-01
First Post:
2019-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MDR EZ Pass and Precision Flexible Reamer
Sponsor:
Zimmer Biomet
Organization:
Study Overview
Official Title:
Post-market Clinical Follow-up Study to Collect Safety, Performance and Clinical Data of the EZPass Suture Passer (Instrumentation) and Precision Flexible Reamers (Instrumentation)- A Retrospective Consecutive Series Study
Status:
COMPLETED
Status Verified Date:
2025-06
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:
None
Brief Summary:
The objective of this study is to confirm the safety and performance on the EZPass Suture Passer Instrumentation and the Precision Flexible Reamer Instrumentation.
Detailed Description:
The primary objective of the study is to assess performance, clinical benefits and safety of the EZPass Suture Passer and the Precision Flexible Reamer Instrumentation.
Performance and clinical benefits will be assessed through an operative survey conducted immediately following intraoperative surgery to determine if the device performed as expected.
Safety will be assessed by recording and analyzing the incidence and frequency of complications, adverse events, and intra-operative revisions.
Performance and clinical benefits will be assessed through an operative survey conducted immediately following intraoperative surgery to determine if the device performed as expected.
Safety will be assessed by recording and analyzing the incidence and frequency of complications, adverse events, and intra-operative revisions.
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?:
True
Is an FDA AA801 Violation?: