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MDR EZ Pass and Precision Flexible Reamer

Rotator Cuff Tear Clinical Trial

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

Clinical Trial 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. Ultimately, clinical performance will be assessed through survey questions that evaluate the safety and performance of these instruments.

Clinical Trial 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. Safety will be assessed by recording and analyzing the incidence and frequency of complications, adverse events, and intra-operative revisions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03914703
Study type Observational
Source Zimmer Biomet
Contact
Status Completed
Phase
Start date August 8, 2019
Completion date April 8, 2024
View Details
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