MDR EZ Pass and Precision Flexible Reamer

Completed

• Conditions: Rotator Cuff Tear; Anterior Cruciate Ligament Injury
• Interventions: Procedure: EZ Pass Suture Passer

• Registration Number: NCT03914703
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2019-04-11
• Study First Submitted QC: 2019-04-11
• Study First Posted: 2019-04-16
• Study Start: 2019-08-08
• Primary Completion: 2023-12-31
• Status Verified: 2024-04
• Study Completion: 2024-04-08
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Precision Flexible Reamer	EZ Pass Suture Passer	Patients who have surgery using the Precision Flexible Reamer Instrument in ACL repair
EZ Pass Suture Passer	EZ Pass Suture Passer	Patients who have surgery using the EZ Pass Suture Passer Instrument either in rotator cuff or soft tissue repair

Primary Outcome Measures

Name	Time	Method
Performance of Instruments based on Patient Questionnaire (EZ Pass Suture Passer and Precision Flexible Reamer)	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
Absence of Instrument Related Serious Adverse Events	Intraoperative	This outcome will measure the frequency of instrument related serious adverse events

Trial Locations

Locations (1)

OrthoCarolina; 🇺🇸 Charlotte, North Carolina, United States