MDR EZ Pass and Precision Flexible Reamer
- Conditions
- Rotator Cuff TearAnterior Cruciate Ligament Injury
- Registration Number
- NCT03914703
- Lead Sponsor
- Zimmer Biomet
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
OrthoCarolina
🇺🇸Charlotte, North Carolina, United States
OrthoCarolina🇺🇸Charlotte, North Carolina, United States