Nanoscope Cost Analysis Study

Starting soon · Not applicable

Conditions studied: Meniscal Tear

In brief

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

Key facts

Study ID

NCT06603740

Run by

Arthrex, Inc.

People needed

10

Starts

2024-11-01

Expected to finish

2025-07-01

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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. -

Where it is running

• Orthopedic Rhode Island — Warwick, Rhode Island, United States

Full record on ClinicalTrials.gov

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