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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two methods for performing a partial meniscectomy, a procedure to treat a torn meniscus in the knee. Researchers seek to determine if a new tool, the NanoScope (a type of arthroscopy device), is more cost-effective than the traditional method. Suitable candidates for this trial have a confirmed meniscal tear, require a simple procedure, and have no severe knee misalignment or other major knee issues.

As an unphased trial, this study allows patients to contribute to innovative research that could enhance future knee treatments.

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 prior data suggests that these methods are safe for partial meniscectomy?

Research has shown that using the NanoScope for partial meniscectomy is generally safe. Studies have found that this method can lead to less pain and faster recovery compared to traditional knee surgery. Patients who underwent partial meniscectomy with the NanoScope reported less pain and better results soon after the procedure. This technique also causes less damage to the knee, making recovery more comfortable. These findings suggest that patients tolerate the NanoScope well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of the Arthrex Nanoscope for partial meniscectomy because it offers a minimally invasive approach with advanced visualization capabilities. Unlike conventional arthroscopy, the Nanoscope is a needle-sized camera, which means it can potentially reduce tissue damage and promote faster recovery times. Its high-resolution imaging allows for more precise surgical maneuvers, which could result in better outcomes for patients with meniscal tears.

What evidence suggests that this trial's treatments could be effective for meniscal tear?

This trial will compare two methods for partial meniscectomy: the Arthrex NanoScope and conventional arthroscopy equipment. Research has shown that using the NanoScope for partial meniscectomy, a type of knee surgery, can lead to less pain and quicker recovery. Specifically, studies have found that patients experience significantly less pain just two weeks after surgery. The NanoScope technique employs a tiny camera, resulting in less fluid in the joint and smaller incisions, which cause less harm to the knee. This method is generally considered safe and may be more effective than conventional arthroscopy. Overall, early findings suggest it is a promising option for those undergoing meniscus surgery. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrial.be clinicaltrial.be/en/details/83782?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Outcomes of the Nanoscopic Partial Meniscectomy Versus ... The authors hypothesize that the Nanoscopic partial menisectomy patients will have less pain and return function faster than standard ...

2. jcesom.marshall.edu jcesom.marshall.edu/news/musom-news/study-shows-partial-meniscus-removal-using-needle-arthroscopy-offers-significantly-less-pain-and-improved-patient-outcomes-two-weeks-following-surgery/

Study shows partial meniscus removal using needle ... The use of a needle-sized scope known as a nanoscope during a partial meniscus tear repair, or meniscectomy, to be associated with significantly decreased pain.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10393789/

Partial meniscectomy using needle arthroscopy associated ... Adoption of a needle arthroscopic technique for partial meniscectomy resulted in significantly improved VAS and KOOS pain scores two-weeks post-operatively.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2212628721001468

Nanoscopic Medial Meniscus Repair The advantages of this technique are less fluid delivered into the joint, decreased size of the portals, and overall less trauma to the knee. Disadvantages of ...

5. withpower.com withpower.com/trial/phase-meniscal-tear-10-2024-4a8cd

Nanoscope vs Conventional Arthroscopy for Meniscal Tear The NanoScope technique for partial meniscectomy is generally considered safe and may result in less pain and quicker recovery compared to traditional ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05617807

Outcomes of the Nanoscopic Partial Meniscectomy Versus ... The authors hypothesize that the Nanoscopic partial menisectomy patients will have less pain and return function faster than standard arthroscopy.

7. arthrex.com arthrex.com/resources/VID1-004257-en-US/comparison-study-of-nano-arthroscopy-and-conventional-arthroscopy

Comparison Study of Nano Arthroscopy and Conventional ... Partial meniscectomies using needle arthroscopy are associated with significantly less pain and improved patient-reported outcomes 2 weeks post-op.