Trials Sponsors Conditions Drugs Pricing

Conditions

Anterior Cruciate Ligament Injury Rotator Cuff Tear

Outcome Measures

Primary Outcomes (2)

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.
Intraoperative
Absence of Instrument Related Serious Adverse Events
This outcome will measure the frequency of instrument related serious adverse events
Intraoperative

Study Arms (2)

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

Precision Flexible Reamer

Patients who have surgery using the Precision Flexible Reamer Instrument in ACL repair

Procedure: EZ Pass Suture Passer

Interventions

EZ Pass Suture PasserProcedure

Instruments used to help with rotator cuff or ACL repair

EZ Pass Suture PasserPrecision Flexible Reamer

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

You may qualify if:

EZ Pass Suture Passer:

Sponsors & Collaborators

Zimmer Biomet
Industrylead

Study Sites (1)

OrthoCarolina

Charlotte, North Carolina, 28277, United States

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesRotator Cuff Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and InjuriesRuptureShoulder InjuriesTendon Injuries

Limitations and Caveats

Among the limitations of the study was that it was comprised of a single center of non-randomized enrollment. Additional limitations include no patient reported outcome measures or post-operative follow-up visits.

Results Point of Contact

Title: Jarrod Hunnicutt, Clinical Affairs Manager
Organization: Zimmer Biomet

Study Officials

Erin Osborn
Zimmer Biomet
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

73 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: RETROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 11, 2019

First Posted

April 16, 2019

Study Start

August 8, 2019

Actual (reported)

MDR EZ Pass and Precision Flexible Reamer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

EZ Pass Suture Passer

Precision Flexible Reamer

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

EZ Pass Suture Passer

Precision Flexible Reamer

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations