NCT03914703

MDR EZ Pass and Precision Flexible Reamer

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
• Phase: —
• Study type: Observational
• Enrollment: 73 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anterior Cruciate Ligament Injury
• Rotator Cuff Tear

Interventions

Type	Name	Description
PROCEDURE	EZ Pass Suture Passer	Instruments used to help with rotator cuff or ACL repair

Timeline

• Start date: 2019-08-08
• Primary completion: 2023-12-31
• Completion: 2024-04-08
• First posted: 2019-04-16
• Last updated: 2025-07-01
• Results posted: 2025-07-01

Locations

1 site across 1 country: United States