Randomized Arthrex Nano Arthroscopy in Arthroscopic ACL vs Conventional Arthroscopy

NCT07553975 | Not Yet Recruiting FDA Device

• 1 other identifier: 25-2232
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anterior Cruciate Ligament

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.

  immediately postoperatively

• Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.

  immediately postoperatively

• Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.

  immediately postoperatively

• Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.

  immediately postoperatively

• Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.

  immediately postoperatively

Other Outcomes (1)

• Measure of completeness of diagnostic arthroscopy: Arthrex Nanoscope 2.0 vs standard arthroscope

  4 weeks postoperatively

Study Arms (2)

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.

Device: ACL surgery using Arthrex NanoScope

ACL surgery using conventional arthroscopy

ACTIVE COMPARATOR

Conventional arthroscopy using standard of care equipment

Procedure: ACL surgery using conventional arthroscopy

Interventions

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.

ACL surgery using Arthrex NanoScope

ACL surgery using conventional arthroscopy PROCEDURE

Conventional arthroscopy using standard of care equipment

ACL surgery using conventional arthroscopy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Arthrex, Inc.: collaborator

Study Officials

• Rachel M Frank, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory Ottenberg

CONTACT

303-724-6538; GREGORY.OTTENBERG@CUANSCHUTZ.EDU

Hana Durkee

CONTACT

hana.durkee@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: April 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04