Nanoscope Cost Analysis Study

Randomized Study Evaluating Cost of Arthrex Nano Arthroscopy Products in Arthroscopic Knee Meniscectomy Versus Conventional Arthroscopy

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

Study Overview

• Status: Not yet recruiting
• Conditions: Meniscal Tear
• Intervention / Treatment: Device: Arthrex Nanoscope; Device: Conventional Arthroscopy without Arthrex Nanoscope

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carolie I Caraci, BA; Phone Number: 18009337001; Email: caroline.caraci@arthrex.com

Study Locations

• United States
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Orthopedic Rhode Island
      • Contact: Jennifer Stedman; Phone Number: 401-777-7000
      • Contact: Michael Bradley, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Partial meniscectomy using the Arthrex Nanoscope	Device: Arthrex Nanoscope; Arthrex's all-in-one disposable, 2 mm, chip-on-tip camera system now allows surgeons to miniaturize their treatment solutions
Other: Partial meniscectomy using conventional arthroscopy equipment	Device: Conventional Arthroscopy without Arthrex Nanoscope; partial meniscectomy using conventional arthroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Knee Documentation Committee (IKDC) Score	The IKDC Questionnaire is a subjective scale that provides patients with an overall function score. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. The symptoms subscale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee. The questions prompt an answer 0-10. The total score is interpreted as a measure of function with higher scores representing higher levels of function.	Pre Operative, 2 weeks and 6 weeks post op
Visual Analogue Scale (VAS)	The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels.v	Pre Operative, 2 weeks and 6 weeks post op

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Injury and Osteoarthritis outcome Score (KOOS)	KOOS is a five-subscale patient-reported instrument intended for use from the time of knee injury to the development of osteoarthritis. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures	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
PROMIS Physical Function 13a scale		preop, 2 weeks post op, and 6 weeks post op

Collaborators and Investigators

• Sponsor: Arthrex, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: August 21, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: AIRR-0211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No