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The objective of this study is to confirm the safety and performance on the EZPass Suture Passer Instrumentation and the Precision Flexible Reamer Instrumentation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EZ Pass Suture Passer | Patients who have surgery using the EZ Pass Suture Passer Instrument either in rotator cuff or soft tissue repair |
| |
| Precision Flexible Reamer | Patients who have surgery using the Precision Flexible Reamer Instrument in ACL repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EZ Pass Suture Passer | Procedure | Instruments used to help with rotator cuff or ACL repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
Exclusion Criteria
EZ Pass Suture Passer:
- Any use other than the approved uses indicated in the Instructions for Use (IFU).
Precision Flexible Reamer:
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The study population should be a consecutive series of subjects where the EZPass Suture Passer or Precision Flexible Reamer instrumentation will be used.
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| Name | Affiliation | Role |
|---|---|---|
| Erin Osborn | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrthoCarolina | Charlotte | North Carolina | 28277 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients who have received either the EZ Pass Suture Passer or the Precision Flexible Reamer.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Intraoperative |
|
Adverse events occurring on the day of surgery were reported and assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Instrument Malfunction | Surgical and medical procedures | Systematic Assessment | Kite broke when grabbed with Suture Grasper |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jarrod Hunnicutt, Clinical Affairs Manager | Zimmer Biomet | 574-453-7834 | jarrod.hunnicutt@zimmerbiomet.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2021 | Feb 25, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D012421 | Rupture |
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| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | 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.
|
|
| Primary | Absence of Instrument Related Serious Adverse Events | This outcome will measure the frequency of instrument related serious adverse events | Questionnaire will be used to assess whether subjects had any instrument-related serious adverse events. Responses are yes/no. | Posted | Count of Participants | Participants | Intraoperative |
|
|
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| 0 |
| 51 |
| 0 |
| 51 |
| 5 |
| 51 |
| EG001 | Precision Flexible Reamer | 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. | 0 | 22 | 0 | 22 | 2 | 22 |
|
| Instrument Malfunction | Surgical and medical procedures | Systematic Assessment | Kite would not advance |
|
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| D000070599 |
| Shoulder Injuries |
| D013708 | Tendon Injuries |