Clinical trial NCT06603740: Nanoscope Cost Analysis Study
Official title: Randomized Study Evaluating Cost of Arthrex Nano Arthroscopy Products in Arthroscopic Knee Meniscectomy Versus Conventional Arthroscopy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Meniscal Tear
Lead sponsor: Arthrex, Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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


Eligibility criteria: 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. -

Primary outcomes:
measure: Cost Comparison (TDBC)
timeFrame: Operative Visit
Secondary outcomes:
measure: International Knee Documentation Committee (IKDC) Score
timeFrame: Pre Operative, 2 weeks and 6 weeks post op
measure: Visual Analogue Scale (VAS)
timeFrame: Pre Operative, 2 weeks and 6 weeks post op
Other outcomes:
measure: Knee Injury and Osteoarthritis outcome Score (KOOS)
timeFrame: Pre Operative, 2 weeks and 6 weeks post op
measure: PROMIS Pain Interference 6a scale
timeFrame: preop, 2 weeks post op, and 6 weeks post op
measure: PROMIS Pain Intensity 3a scale
timeFrame: preop, 2 weeks post op, and 6 weeks post op
measure: PROMIS Physical Function 13a scale
timeFrame: preop, 2 weeks post op, and 6 weeks post op
Locations:
city: Warwick
country: United States
facility: Orthopedic Rhode Island
state: Rhode Island
Study officials:
References: