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.
Subject is 18 - 60 years of age.
Subject body mass index (BMI) is 40 or lower (BMI ≤ 40).
Subject signed informed consent and is willing and able to comply with all study requirements and follow-up visits.
Confirmed ACL injury by MRI and physical exam as per standard of care.
Revision ACL case.
Current bilateral knee injury.
Insufficient quantity or quality of bone.
Blood supply limitations and previous infections which may retard healing.
Parallel
ACL surgery using Arthrex NanoScope
DeviceThe 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.
ACL surgery using conventional arthroscopy
Procedure/SurgeryConventional 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)
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)
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)
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)
Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.
7\. OR Metrics Surgical Time, Units: Minutes
Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.
8\. OR Metrics Tourniquet Time, Units: Minutes
Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.
9\. OR Metrics Fluid Utilized, Units: milliliters
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
Measure of completeness of diagnostic arthroscopy: Arthrex Nanoscope 2.0 vs standard arthroscope
Diagnostic knee arthroscopy examination, with independent (blind to type of scope used in procedure) review of examination results. The surgery will be recorded, and the independent (blinded) observer will watch a video recording and answer the questions below: Were the following Completed? (Yes/No): Inspect suprapatellar pouch Evaluate patellofemoral articulation Evaluate patella (medial/lateral and inferior/superior) Inspect the lateral gutter Inspect the popliteus tendon and recess Inspect medial gutter Inspect and probe medial femoral condyle Inspect and probe medial tibial plateau Inspect and probe anterior, middle and posterior medial meniscus Inspect and probe ACL/PCL/ligamentum Inspect and probe lateral femoral condyle Inspect and probe lateral tibial plateau Inspect and probe anterior, middle and posterior lateral meniscus Evaluate passive tracking of patella in trochlear groove Was the arthroscopy completed?
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
Arthrex, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
