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Completed

NCT Number: NCT03914703

MDR EZ Pass and Precision Flexible Reamer

The objective of this study is to confirm the safety and performance on the EZPass Suture Passer Instrumentation and the Precision Flexible Reamer Instrumentation.

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Key information

Conditions

Anterior Cruciate Ligament Injury Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Rotator Cuff Injuries Rotator Cuff Tear Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OrthoCarolina

Charlotte, North Carolina, 28277, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • EZ Pass Suture Passer:
  • Intended as an open or arthroscopic instrument utilized in conjunction with a nitinol wire or nylon monofilament to aid in passing suture through soft tissue.
  • Precision Flexible Reamer:
  • This device is a hand held, or hand-manipulated device, intended to be used in ACL and PCL reconstruction surgeries and is intended for medical purposes to manipulate tissue, or for use with other devices in these surgeries.

Exclusion criteria

  • EZ Pass Suture Passer:
  • Any use other than the approved uses indicated in the Instructions for Use (IFU).
  • Precision Flexible Reamer:
  • Any use other than the approved uses indicated in the Instructions for Use (IFU).

Treatment and study plan

EZ Pass Suture Passer

Procedure

Instruments used to help with rotator cuff or ACL repair

Primary outcomes

  1. Performance of Instruments (EZ Pass Suture Passer and Precision Flexible Reamer)

    Time frame: Intraoperative

    Questionnaire was completed to assess if the Instrument Performed as Expected. Surgeon provided yes/no answers on their opinion if the instrument performed as expected during the procedure.

  2. Absence of Instrument Related Serious Adverse Events

    Time frame: Intraoperative

    This outcome will measure the frequency of instrument related serious adverse events

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Apr 16, 2019
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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