Trial Outcomes & Findings for MDR EZ Pass and Precision Flexible Reamer (NCT NCT03914703)
NCT ID: NCT03914703
Last Updated: 2025-07-01
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
73 participants
Primary outcome timeframe
Intraoperative
Results posted on
2025-07-01
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
22
|
|
Overall Study
COMPLETED
|
51
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
EZ Pass Suture Passer
n=51 Participants
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
|
Precision Flexible Reamer
n=22 Participants
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
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.1 years
n=51 Participants
|
30.6 years
n=22 Participants
|
47.02 years
n=73 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=51 Participants
|
9 Participants
n=22 Participants
|
31 Participants
n=73 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=51 Participants
|
13 Participants
n=22 Participants
|
42 Participants
n=73 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: IntraoperativeQuestionnaire 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.
Outcome measures
| Measure |
EZ Pass Suture Passer
n=51 Participants
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
|
Precision Flexible Reamer
n=22 Participants
Patients who have surgery using the Precision Flexible Reamer Instrument in ACL repair
Precision Flexible Reamer: A handheld device intended to be used in ACL and PCL reconstruction surgeries to manipulate tissue, or in conjunction with other devices in these surgeries.
|
|---|---|---|
|
Performance of Instruments (EZ Pass Suture Passer and Precision Flexible Reamer)
Performed as Expected
|
49 Participants
|
22 Participants
|
|
Performance of Instruments (EZ Pass Suture Passer and Precision Flexible Reamer)
Did Not Perform as Expected
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: IntraoperativePopulation: Questionnaire will be used to assess whether subjects had any instrument-related serious adverse events. Responses are yes/no.
This outcome will measure the frequency of instrument related serious adverse events
Outcome measures
| Measure |
EZ Pass Suture Passer
n=51 Participants
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
|
Precision Flexible Reamer
n=22 Participants
Patients who have surgery using the Precision Flexible Reamer Instrument in ACL repair
Precision Flexible Reamer: A handheld device intended to be used in ACL and PCL reconstruction surgeries to manipulate tissue, or in conjunction with other devices in these surgeries.
|
|---|---|---|
|
Absence of Instrument Related Serious Adverse Events
Subject with No Instrument-Related Serious Adverse Event
|
51 Participants
|
22 Participants
|
|
Absence of Instrument Related Serious Adverse Events
Subject with Instrument-Related Serious Adverse Event
|
0 Participants
|
0 Participants
|
Adverse Events
EZ Pass Suture Passer
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Precision Flexible Reamer
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EZ Pass Suture Passer
n=51 participants at risk
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
|
Precision Flexible Reamer
n=22 participants at risk
Patients who have surgery using the Precision Flexible Reamer Instrument in ACL repair
Precision Flexible Reamer: handheld device intended to be used in ACL and PCL reconstruction surgeries to manipulate tissue, or in conjunction with other devices in these surgeries.
|
|---|---|---|
|
Surgical and medical procedures
Instrument Malfunction
|
5.9%
3/51 • Adverse events occurring on the day of surgery were reported and assessed.
|
0.00%
0/22 • Adverse events occurring on the day of surgery were reported and assessed.
|
Additional Information
Jarrod Hunnicutt, Clinical Affairs Manager
Zimmer Biomet
Phone: 574-453-7834
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place