Nanoscope Cost Analysis Study

NCT ID: NCT06603740

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2025-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Partial meniscectomy using the Arthrex Nanoscope

Group Type: EXPERIMENTAL

Arthrex Nanoscope

Intervention Type: 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 conventional arthroscopy equipment

Group Type: OTHER

Conventional Arthroscopy without Arthrex Nanoscope

Intervention Type: DEVICE

partial meniscectomy using conventional arthroscopy

Interventions

Arthrex Nanoscope

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

Intervention Type: DEVICE

Conventional Arthroscopy without Arthrex Nanoscope

partial meniscectomy using conventional arthroscopy

Intervention Type: DEVICE

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. -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Arthrex, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Orthopedic Rhode Island

Warwick, Rhode Island, United States

Countries

United States

Central Contacts

Carolie I Caraci, BA

Role: CONTACT

caroline.caraci@arthrex.com

18009337001

Facility Contacts

Jennifer Stedman

Role: primary

401-777-7000

Michael Bradley, MD

Role: backup

Other Identifiers

AIRR-0211

Identifier Type: -

Identifier Source: org_study_id