Randomized Arthrex Nano Arthroscopy in Arthroscopic ACL vs Conventional Arthroscopy

Randomized Study Evaluating Cost of Arthrex Nano Arthroscopy Products in Arthroscopic Knee ACL Surgery Versus Conventional Arthroscopy

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 Overview

• Status: Not yet recruiting
• Conditions: Anterior Cruciate Ligament
• Intervention / Treatment: Device: ACL surgery using Arthrex NanoScope; Procedure: ACL surgery using conventional arthroscopy

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hana Durkee; Email: hana.durkee@cuanschutz.edu
• Study Contact Backup: Name: Gregory Ottenberg; Phone Number: 303-724-6538; Email: GREGORY.OTTENBERG@CUANSCHUTZ.EDU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.
• Subjects not excluded for having meniscal pathology that requires resection or repair.
• Subjects not excluded for having lateral-extra-articular tenodesis

Exclusion Criteria:

• Revision ACL case.
• Current bilateral knee injury.
• Insufficient quantity or quality of bone.
• Blood supply limitations and previous infections which may retard healing.
• Subjects that are skeletally immature.
• Advanced Osteoarthritis; Kellgren Lawrence ≥ 2
• Fracture of the lower extremities within 6 months prior to screening.
• Previous surgery on the affected knee within 12 months related to the ACL reconstruction, prior to screening.
• Sensitivity to silicone, polyester, nylon, FD&C Blue No. 2 dye and beeswax.
• Other concomitant disease that would interfere with study outcomes.
• Subject is included in a vulnerable population (child, prisoner, etc.).
• Conditions that tend to limit the patient's ability or willingness to restrict activities, follow directions, or perform online subject assessments during the healing period.
• Subject is requesting or receiving Worker's compensation related to the knee injury.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACL surgery using Arthrex NanoScope; 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.	Device: ACL surgery using Arthrex NanoScope; 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.
Active Comparator: ACL surgery using conventional arthroscopy; Conventional arthroscopy using standard of care equipment	Procedure: ACL surgery using conventional arthroscopy; Conventional arthroscopy using standard of care equipment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	From enrollment to 2 years

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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?	4 weeks postoperatively

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Arthrex, Inc.
• Investigators: Principal Investigator: Rachel M Frank, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 25-2232

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes