Nanoscope vs Conventional Arthroscopy for Meniscal Tear

Overseen By Carolie I Caraci, BA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Arthrex, Inc.

Disqualifiers: Chondral lesion, Bilateral injury, Osteoarthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

10 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of this treatment for meniscal tear?

The research suggests that using advanced visualization tools like endoscopes and exoscopes can improve surgical procedures by providing better views and less invasive options, which may enhance the effectiveness of treatments like partial meniscectomy. ^{1 2 3 4 5}

Is the NanoScope technique safe for partial meniscectomy?

The NanoScope technique for partial meniscectomy is generally considered safe and may result in less pain and quicker recovery compared to traditional methods. It uses smaller instruments and does not require large incisions, which can reduce the risk of injury to surrounding tissues. ^{6 7 8 9 10}

How does the treatment using NanoScope differ from other treatments for meniscal tear?

The NanoScope treatment for meniscal tears is unique because it uses a smaller, more flexible endoscope, which allows for better visualization and potentially less invasive surgery compared to conventional arthroscopy. This can lead to reduced recovery time and less trauma to surrounding tissues. ^{1 3 11 12 13}

Eligibility Criteria

This clinical trial is for individuals with a meniscal tear, which is an injury to the knee cartilage. Specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed requirements.

Inclusion Criteria

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

My knee's alignment is within normal range according to X-rays or clinical assessment.

Exclusion Criteria

My bones are weak or not enough in quantity.

Sensitivity to silicone, polyester, nylon, FD&C Blue No. 2 dye and beeswax

Subject is included in a vulnerable population (child, prisoner, etc)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Operative

Participants undergo partial meniscectomy using either NanoScope or conventional arthroscopy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments using IKDC, VAS, and KOOS scores

6 weeks

2 visits (in-person) at 2 weeks and 6 weeks post-op

Treatment Details

Interventions

• Partial Meniscectomy using Conventional Arthroscopy
• Partial Meniscectomy using NanoScope

Trial Overview The trial is comparing the costs of two types of knee surgery: one using a new tool called Arthrex Nanoscope and another using conventional arthroscopy without this tool in a standard operating room setting.

Participant Groups

Group I: Partial meniscectomy using the Arthrex Nanoscope Experimental Treatment 1 Intervention

Group II: Partial meniscectomy using conventional arthroscopy equipment Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Arthrex, Inc.

Lead Sponsor

Trials

48

Recruited

30,200+

References

1. United States pubmed.ncbi.nlm.nih.gov

Endoscope-assisted vestibular neurectomy. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Microsurgical Wiltse Paraspinal Approach Using a Low-Budget Exoscope. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Initial Experience Using a High-Definition 3-Dimensional Exoscope System for Microneurosurgery. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Endoscope-assisted microsurgery of the corpus callosum. [2005]

5. United States pubmed.ncbi.nlm.nih.gov

Pre-clinical Comparison of a High-Definition 3-Dimensional Exoscope and an Operating Microscope: A Prospective Randomized Crossover Study. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Incisionless Partial Medial Meniscectomy. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Nanoscopic Medial Meniscus Repair. [2021]

8. India pubmed.ncbi.nlm.nih.gov

Partial meniscectomy using needle arthroscopy associated with significantly less pain and improved patient reported outcomes at two weeks after surgery: A comparison to standard knee arthroscopy. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Diagnostic Needle Arthroscopy and Partial Medial Meniscectomy Using Small Bore Needle Arthroscopy. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Is Wrist Arthroscopy Safer with the Nanoscope? [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Endoscopy in neuro-otologic surgery. [2019]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Surgeon's comfort: The ergonomics of a robotic exoscope using a head-mounted display. [2022]

13. New Zealand pubmed.ncbi.nlm.nih.gov

Combined use of high-reflective index vitrectomy meniscus contact lens and a noncontact wide-angle viewing system in vitreous surgery. [2022]