Nanoscope Cost Analysis Study

NCT06603740 | Not Yet Recruiting FDA Device

• 1 other identifier: AIRR-0211
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Meniscal Tear

Outcome Measures

Primary Outcomes (1)

• Cost Comparison (TDBC)

  Cost comparison using the time-drive activity-based costing (TDABC) study design between NanoScope versus conventional arthroscopy for partial meniscectomy in a traditional OR setting.

  Operative Visit

Secondary Outcomes (2)

• International Knee Documentation Committee (IKDC) Score

  Pre Operative, 2 weeks and 6 weeks post op

• Visual Analogue Scale (VAS)

  Pre Operative, 2 weeks and 6 weeks post op

Other Outcomes (4)

• Knee Injury and Osteoarthritis outcome Score (KOOS)

  Pre Operative, 2 weeks and 6 weeks post op

• PROMIS Pain Interference 6a scale

  preop, 2 weeks post op, and 6 weeks post op

• PROMIS Pain Intensity 3a scale

  preop, 2 weeks post op, and 6 weeks post op

Study Arms (2)

Partial meniscectomy using the Arthrex Nanoscope

EXPERIMENTAL

Device: Arthrex Nanoscope

Partial meniscectomy using conventional arthroscopy equipment

OTHER

Device: Conventional Arthroscopy without Arthrex Nanoscope

Interventions

Arthrex Nanoscope DEVICE

Arthrex's all-in-one disposable, 2 mm, chip-on-tip camera system now allows surgeons to miniaturize their treatment solutions

Partial meniscectomy using the Arthrex Nanoscope

Conventional Arthroscopy without Arthrex Nanoscope DEVICE

partial meniscectomy using conventional arthroscopy

Partial meniscectomy using conventional arthroscopy equipment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Arthrex, Inc.: lead

Study Sites (1)

Orthopedic Rhode Island

Warwick, Rhode Island, 02886, United States

Location

Central Study Contacts

Carolie I Caraci, BA

CONTACT

18009337001; caroline.caraci@arthrex.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: September 19, 2024
• Study Start: November 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: July 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)