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 Details — Status: Completed

Administrative data

• NCT number: NCT03914703
• Other study ID #: MDRG2017-89MS-32SM
• Status: Completed
• Start date: August 8, 2019
• Est. completion date: April 8, 2024

Study information

• Verified date: April 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: April 8, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Injury
• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

Procedure:
• EZ Pass Suture Passer
Instruments used to help with rotator cuff or ACL repair

Locations

Country	Name	City	State
United States	OrthoCarolina	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of Instruments based on Patient Questionnaire (EZ Pass Suture Passer and Precision Flexible Reamer)	Questionnaire will be completed to assess if the Instrument Perform as Expected. Questions to include are: Which Instrument was used? EZ Pass Suture Passer or Precision Flexible Reamer Which Procedure was performed? Rotator Cuff or ACL OR Time (Skin to Skin) in Minutes Did the instrument perform as expected? Yes or No Did the Instrument break? Yes or No Blood Loss during Surgery? Minimal, Moderate or Severe Intraoperative Complications Yes or No	Intraoperative
Primary	Absence of Instrument Related Serious Adverse Events	This outcome will measure the frequency of instrument related serious adverse events	Intraoperative