Nanoscope Cost Analysis Study

Arthrex

Status: Not yet enrolling

Conditions: Meniscal Tear

Treatments: Device: Arthrex Nanoscope; Device: Conventional Arthroscopy without Arthrex Nanoscope

Study type: Interventional

Funder types: Industry

Identifiers

NCT06603740

AIRR-0211

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subject requires simple partial posterior or mid-body meniscectomy.
2. Subject is 18 - 60 years of age.
3. Subject body mass index (BMI) is 35 or lower (BMI ≤ 35).
4. Subject signed informed consent and is willing and able to comply with all study requirements and follow-up visits.
5. Confirmed meniscal injury by physical exam as per standard of care.
6. 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

1. Subject requires complex repair or anterior meniscectomy.
2. Subject has a concomitant chondral lesion of the ipsilateral knee in addition to meniscal tear.
3. Current bilateral knee injury.
4. Insufficient quantity or quality of bone.
5. Blood supply limitations and previous infections which may retard healing.
6. Congenital ligamentous hypermobility defined by Beighton score 4 or 5.
7. Locked knee or haemarthrosis.
8. Subjects that are skeletally immature.
9. Advanced Osteoarthritis; Kellgren Lawrence ≥ 2
10. Fracture of the lower extremities within 6 months prior to screening.
11. Previous surgery on the affected knee within 12 months prior to screening.
12. Sensitivity to silicone, polyester, nylon, FD&C Blue No. 2 dye and beeswax.
13. Other concomitant disease that would interfere with study outcomes.
14. Subject is included in a vulnerable population (child, prisoner, etc).
15. 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.
16. Subject is requesting or receiving Worker's compensation related to the knee injury. -

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Partial meniscectomy using the Arthrex Nanoscope

Experimental group

Treatment:

Device: Arthrex Nanoscope

Partial meniscectomy using conventional arthroscopy equipment

Other group

Treatment:

Device: Conventional Arthroscopy without Arthrex Nanoscope