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NCT Number: NCT07553975

Randomized Arthrex Nano Arthroscopy in Arthroscopic ACL vs 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.

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Key information

Conditions

Anterior Cruciate Ligament

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 conventional arthroscopy

Procedure

Conventional arthroscopy using standard of care equipment

Primary outcomes

  1. Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.

    Time frame: From enrollment to 2 years

    • Patient Reported Outcomes Knee Injury and Osteoarthritis Outcome Score (KOOS)

  2. Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.

    Time frame: From enrollment to 2 years

    • Patient Reported Outcomes Visual Analog Scale (VAS)

  3. Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.

    Time frame: From enrollment to 2years

    • Patient Reported Outcomes Single Assessment Numeric Evaluation (SANE)

  4. Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.

    Time frame: From enrollment to 2 years

    • Patient Reported Outcomes International Knee Documentation Committee Subjective Measure (IKDC)

  5. Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.

    Time frame: From enrollment to 2 years

    • Patient Reported Outcomes Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a scale

  6. Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.

    Time frame: From enrollment to 2 years

    • Patient Reported Outcomes Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference 6a scale

Secondary outcomes

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

    Time frame: immediately postoperatively

    • OR Metrics Surgical Time, Units: Minutes

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

    Time frame: immediately postoperatively

    • OR Metrics Tourniquet Time, Units: Minutes

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

    Time frame: immediately postoperatively

    • OR Metrics Fluid Utilized, Units: milliliters

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

    Time frame: immediately postoperatively

    • OR Metrics Anesthetic Type Used: general, local, or regional

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

    Time frame: immediately postoperatively

    • OR Metrics Anesthetic Amount Used: Minutes, milliliters

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

    Time frame: immediately postoperatively

    • OR Metrics OR Turnover Time, Units: minutes

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

    Time frame: 1 month postoperatively

    • OR Metrics Cost (nanoscope 2.0 versus conventional arthroscopy), Units: US Dollars

Other outcomes

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

    Time frame: 4 weeks postoperatively

    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?

Study contacts

Contact information is provided by the study sponsor or research team.

Gregory Ottenberg

CONTACT

[email protected]

303-724-6538

Hana Durkee

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Arthrex, Inc.

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 28, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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