The study is a pilot study designed to generate preliminary data regarding the cost of ACL surgery using NanoScope versus conventional arthroscopy in a traditional operating room (OR) setting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
The rod-lens arthroscope has been the standard of care in the operating room for more than 40 years. Arthrex's all-in-one disposable, 2 mm, chip-on-tip camera system now allows surgeons to miniaturize their treatment solutions.
Conventional arthroscopy using standard of care equipment
Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.
1\. Patient Reported Outcomes Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: From enrollment to 2 years
Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.
2\. Patient Reported Outcomes Visual Analog Scale (VAS)
Time frame: From enrollment to 2 years
Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.
3\. Patient Reported Outcomes Single Assessment Numeric Evaluation (SANE)
Time frame: From enrollment to 2years
Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.
4\. Patient Reported Outcomes International Knee Documentation Committee Subjective Measure (IKDC)
Time frame: From enrollment to 2 years
Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.
5\. Patient Reported Outcomes Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a scale
Time frame: From enrollment to 2 years
Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.
6\. Patient Reported Outcomes Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference 6a scale
Time frame: From enrollment to 2 years
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Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.
7\. OR Metrics Surgical Time, Units: Minutes
Time frame: immediately postoperatively
Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.
8\. OR Metrics Tourniquet Time, Units: Minutes
Time frame: immediately postoperatively
Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.
9\. OR Metrics Fluid Utilized, Units: milliliters
Time frame: immediately postoperatively
Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.
10\. OR Metrics Anesthetic Type Used: general, local, or regional
Time frame: immediately postoperatively
Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.
10\. OR Metrics Anesthetic Amount Used: Minutes, milliliters
Time frame: immediately postoperatively
Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.
12\. OR Metrics OR Turnover Time, Units: minutes
Time frame: immediately postoperatively
Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.
13\. OR Metrics Cost (nanoscope 2.0 versus conventional arthroscopy), Units: US Dollars
Time frame: 1 month postoperatively