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MDR EZ Pass and Precision Flexible Reamer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03914703
Recruitment Status : Enrolling by invitation
First Posted : April 16, 2019
Last Update Posted : September 24, 2020
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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

Condition or disease Intervention/treatment
Anterior Cruciate Ligament Injury Rotator Cuff Tear Procedure: EZ Pass Suture Passer

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.

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

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Study Type : Observational
Estimated Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : August 8, 2019
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : May 30, 2021

Group/Cohort Intervention/treatment
EZ Pass Suture Passer
Patients who have surgery using the EZ Pass Suture Passer Instrument either in rotator cuff or soft tissue repair
Procedure: EZ Pass Suture Passer
Instruments used to help with rotator cuff or ACL repair

Precision Flexible Reamer
Patients who have surgery using the Precision Flexible Reamer Instrument in ACL repair
Procedure: EZ Pass Suture Passer
Instruments used to help with rotator cuff or ACL repair




Primary Outcome Measures :
  1. Performance of Instruments based on Patient Questionnaire (EZ Pass Suture Passer and Precision Flexible Reamer) [ Time Frame: Intraoperative ]

    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


  2. Absence of Instrument Related Serious Adverse Events [ Time Frame: Intraoperative ]
    This outcome will measure the frequency of instrument related serious adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population should be a consecutive series of subjects where the EZPass Suture Passer or Precision Flexible Reamer instrumentation will be used.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914703


Locations
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United States, North Carolina
OrthoCarolina
Charlotte, North Carolina, United States, 28277
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Study Director: Kacy Arnold Zimmer Biomet
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT03914703    
Other Study ID Numbers: MDRG2017-89MS-32SM
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: September 24, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Anterior Cruciate Ligament Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Knee Injuries
Leg Injuries