Not yet recruiting NCT06603740
Nanoscope Cost Analysis Study
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: Arthrex Nanoscope, Conventional Arthroscopy without Arthrex Nanoscope.
- Who it may be relevant to
- Registry conditions: Meniscal Tear. 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
- United States
- 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 Meniscectomy Versus Conventional Arthroscopy
Overview
The study is a pilot study designed to generate preliminary data regarding the cost of partial meniscectomy using NanoScope versus conventional arthroscopy in a traditional operating room (OR) setting
Interventions
- Device Arthrex Nanoscope
Arthrex's all-in-one disposable, 2 mm, chip-on-tip camera system now allows surgeons to miniaturize their treatment solutions - Device Conventional Arthroscopy without Arthrex Nanoscope
partial meniscectomy using conventional arthroscopy
Primary outcome measures
- Cost Comparison (TDBC) [Time frame: Operative Visit]
Secondary outcome measures (2)
- International Knee Documentation Committee (IKDC) Score [Time frame: Pre Operative, 2 weeks and 6 weeks post op]
- Visual Analogue Scale (VAS) [Time frame: Pre Operative, 2 weeks and 6 weeks post op]
Eligibility criteria
Inclusion criteria
- Subject requires simple partial posterior or mid-body meniscectomy.
- Subject is 18 - 60 years of age.
- Subject body mass index (BMI) is 35 or lower (BMI ≤ 35).
- Subject signed informed consent and is willing and able to comply with all study requirements and follow-up visits.
- Confirmed meniscal injury by physical exam as per standard of care.
- Normal mechanical alignment; < 5° varus and < 7° valgus, of the affected knee by clinical assessment or X-Rays as per standard of care
Exclusion criteria
- Subject requires complex repair or anterior meniscectomy.
- Subject has a concomitant chondral lesion of the ipsilateral knee in addition to meniscal tear.
- Current bilateral knee injury.
- Insufficient quantity or quality of bone.
- Blood supply limitations and previous infections which may retard healing.
- Congenital ligamentous hypermobility defined by Beighton score 4 or 5.
- Locked knee or haemarthrosis.
- 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 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
- Health services research
Study locations
United States · 1 center
- Orthopedic Rhode Island — Warwick
Identifiers
NCT: NCT06603740 · AIRR-0211