Anterior Cruciate Ligament
Conditions
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.
Interventions
DEVICEACL 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.
PROCEDUREACL surgery using conventional arthroscopy
Conventional arthroscopy using standard of care equipment
Sponsors
University of Colorado, Denver
Arthrex, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy. | From enrollment to 2 years | 1\. Patient Reported Outcomes Knee Injury and Osteoarthritis Outcome Score (KOOS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction. | immediately postoperatively | 7\. OR Metrics Surgical Time, Units: Minutes |
Contacts
CONTACTGregory Ottenberg
CONTACTHana Durkee
PRINCIPAL_INVESTIGATORRachel M Frank, MD
University of Colorado, Denver
Outcome results
None listed