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NCT03914703 Clinical Trial

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
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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).

Study Design

Related Conditions & MeSH terms

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
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