Menu
Not yet recruiting NCT07553975

Randomized Arthrex Nano Arthroscopy in Arthroscopic ACL vs Conventional Arthroscopy

No phase Interventional Anterior Cruciate Ligament

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ACL surgery using Arthrex NanoScope, ACL surgery using conventional arthroscopy.
Who it may be relevant to
Registry conditions: Anterior Cruciate Ligament. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.
  • Procedure ACL surgery using conventional arthroscopy
    Conventional arthroscopy using standard of care equipment

Primary outcome measures

  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
Secondary outcome measures (7)
  • Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction. [Time frame: immediately postoperatively]
  • Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction. [Time frame: immediately postoperatively]
  • Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction. [Time frame: immediately postoperatively]
  • Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction. [Time frame: immediately postoperatively]
  • Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction. [Time frame: immediately postoperatively]
  • Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction. [Time frame: immediately postoperatively]
  • Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction. [Time frame: 1 month postoperatively]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07553975 · 25-2232

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗