MDR EZ Pass and Precision Flexible Reamer

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-08

Study Completion Date

2024-04-08

Brief Summary

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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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Detailed Description

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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

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Anterior Cruciate Ligament Injury Rotator Cuff Tear

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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EZ Pass Suture Passer

Patients who have surgery using the EZ Pass Suture Passer Instrument either in rotator cuff or soft tissue repair

EZ Pass Suture Passer

Intervention Type PROCEDURE

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

EZ Pass Suture Passer

Intervention Type PROCEDURE

Instruments used to help with rotator cuff or ACL repair

Interventions

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EZ Pass Suture Passer

Instruments used to help with rotator cuff or ACL repair

Intervention Type PROCEDURE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No