Anterior Cruciate Ligament InjuryNCT03914703
MDR EZ Pass and Precision Flexible Reamer
An observational study of Anterior Cruciate Ligament Injury and Rotator Cuff Tear, run by Zimmer Biomet at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Injury, Rotator Cuff Tear
- What is being tested?
- EZ Pass Suture Passer
- Type of treatment
- Surgery or procedure
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2019to 8 Apr 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
The objective of this study is to confirm the safety and performance on the EZPass Suture Passer Instrumentation and the Precision Flexible Reamer Instrumentation.
Read the 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 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.
- Being tested
- EZ Pass Suture Passer
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EZ Pass Suture PasserProcedure or surgery
Instruments used to help with rotator cuff or ACL repair
| Study group | Role | What they receive |
|---|---|---|
| EZ Pass Suture Passer | Patients who have surgery using the EZ Pass Suture Passer Instrument either in rotator cuff or soft tissue repair Receives: Procedure: EZ Pass Suture Passer | |
| Precision Flexible Reamer | Patients who have surgery using the Precision Flexible Reamer Instrument in ACL repair Receives: Procedure: EZ Pass Suture Passer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of Instruments (EZ Pass Suture Passer and Precision Flexible Reamer)
Questionnaire was completed to assess if the Instrument Performed as Expected. Surgeon provided yes/no answers on their opinion if the instrument performed as expected during the procedure.
Measured: Intraoperative
Absence of Instrument Related Serious Adverse Events
This outcome will measure the frequency of instrument related serious adverse events
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start8 Aug 2019
- Primary completion31 Dec 2023
- Study completion8 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erin Osborn, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914703
- Sponsor's protocol ID
- MDRG2017-89MS-32SM
- Status last verified
- Jun 2025
- First submitted
- 11 Apr 2019
- Last updated
- 1 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03914703
- Acronym / sponsor ID
- MDRG2017-89MS-32SM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Posted 1 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to confirm the safety and performance on the EZPass Suture Passer Instrumentation and the Precision Flexible Reamer Instrumentation.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EZ Pass Suture Passer | – | Procedure: EZ Pass Suture PasserPatients who have surgery using the EZ Pass Suture Passer Instrument either in rotator cuff or soft tissue repair |
| Precision Flexible Reamer | – | Procedure: EZ Pass Suture PasserPatients who have surgery using the Precision Flexible Reamer Instrument in ACL repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- EZ Pass Suture Passer:
- Precision Flexible Reamer:
Key exclusion criteria (4 listed)
- EZ Pass Suture Passer:
- Precision Flexible Reamer:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EZ Pass Suture PasserInstruments used to help with rotator cuff or ACL repair | Procedure or surgery | EZ Pass Suture Passer, Precision Flexible Reamer |
Primary outcome
Performance of Instruments (EZ Pass Suture Passer and Precision Flexible Reamer)
Time frame: Intraoperative
Questionnaire was completed to assess if the Instrument Performed as Expected. Surgeon provided yes/no answers on their opinion if the instrument performed as expected during the procedure.
Absence of Instrument Related Serious Adverse Events
Time frame: Intraoperative
This outcome will measure the frequency of instrument related serious adverse events
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Osborn study director
Zimmer Biomet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Injury and Rotator Cuff Tear, run by Zimmer Biomet at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of Instruments (EZ Pass Suture Passer and Precision Flexible Reamer) (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.