Anterior Cruciate Ligament Injury, Rotator Cuff Tear
Conditions
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.
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.
Interventions
PROCEDUREEZ Pass Suture Passer
Instruments used to help with rotator cuff or ACL repair
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance of Instruments (EZ Pass Suture Passer and Precision Flexible Reamer) | 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 | Intraoperative | This outcome will measure the frequency of instrument related serious adverse events |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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: open or arthroscopic instrument utilized in conjunction with a nitinol wire or nylon monofilament to aid in passing suture through soft tissue | 51 |
| Precision Flexible Reamer Patients who have surgery using the Precision Flexible Reamer Instrument in ACL repair
Precision Flexible Reamer: handheld/hand-manipulated device intended to be used in ACL or PCL reconstruction surgeries, intended to manipulate tissue or in conjunction with other devices | 22 |
| Total | 73 |
Baseline characteristics
| Characteristic | EZ Pass Suture Passer | Precision Flexible Reamer | Total |
|---|---|---|---|
| Age, Continuous | 54.1 years | 30.6 years | 47.02 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 22 Participants | 9 Participants | 31 Participants |
| Sex: Female, Male Male | 29 Participants | 13 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 22 |
| other Total, other adverse events | 5 / 51 | 2 / 22 |
| serious Total, serious adverse events | 0 / 51 | 0 / 22 |
Outcome results
Primary
Absence of Instrument Related Serious Adverse Events
This outcome will measure the frequency of instrument related serious adverse events
Time frame: Intraoperative
Population: Questionnaire will be used to assess whether subjects had any instrument-related serious adverse events. Responses are yes/no.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EZ Pass Suture Passer | Absence of Instrument Related Serious Adverse Events | Subject with No Instrument-Related Serious Adverse Event | 51 Participants |
| EZ Pass Suture Passer | Absence of Instrument Related Serious Adverse Events | Subject with Instrument-Related Serious Adverse Event | 0 Participants |
| Precision Flexible Reamer | Absence of Instrument Related Serious Adverse Events | Subject with No Instrument-Related Serious Adverse Event | 22 Participants |
| Precision Flexible Reamer | Absence of Instrument Related Serious Adverse Events | Subject with Instrument-Related Serious Adverse Event | 0 Participants |
Primary
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.
Time frame: Intraoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EZ Pass Suture Passer | Performance of Instruments (EZ Pass Suture Passer and Precision Flexible Reamer) | Performed as Expected | 49 Participants |
| EZ Pass Suture Passer | Performance of Instruments (EZ Pass Suture Passer and Precision Flexible Reamer) | Did Not Perform as Expected | 2 Participants |
| Precision Flexible Reamer | Performance of Instruments (EZ Pass Suture Passer and Precision Flexible Reamer) | Performed as Expected | 22 Participants |
| Precision Flexible Reamer | Performance of Instruments (EZ Pass Suture Passer and Precision Flexible Reamer) | Did Not Perform as Expected | 0 Participants |