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| Name | Class |
|---|---|
| Arthrex, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACL surgery using Arthrex NanoScope | Experimental | 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. |
|
| ACL surgery using conventional arthroscopy | Active Comparator | Conventional arthroscopy using standard of care equipment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACL surgery using Arthrex NanoScope | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 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) | 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) | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction. | 7. OR Metrics Surgical Time, Units: Minutes | immediately postoperatively |
| Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction. |
| Measure | Description | Time Frame |
|---|---|---|
| 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? |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gregory Ottenberg | Contact | 303-724-6538 | GREGORY.OTTENBERG@CUANSCHUTZ.EDU | |
| Hana Durkee | Contact | hana.durkee@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rachel M Frank, MD | University of Colorado, Denver | Principal Investigator |
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| ACL surgery using conventional arthroscopy | Procedure | Conventional arthroscopy using standard of care equipment |
|
| From enrollment to 2 years |
8. OR Metrics Tourniquet Time, Units: Minutes |
| immediately postoperatively |
| Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction. | 9. OR Metrics Fluid Utilized, Units: milliliters | 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 | 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 | 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 | 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 | 1 month postoperatively |
| 4 weeks postoperatively |