Outcomes of the Nanoscopic Partial Meniscectomy Versus Standard Arthroscopic Partial Meniscectomy

NCT05617807 | Recruiting FDA Device

• 1 other identifier: 1926751-2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Standard arthroscopy has been the gold standard for treatment of meniscus tears since the 1980's. The purpose of this study is to analyze the clinical outcomes of using the smaller diameter Nanoscope for partial menisectomy. The authors hypothesize that the Nanoscopic partial menisectomy patients will have less pain and return function faster than standard arthroscopy.

Conditions

Meniscus Tear

Keywords

Arthroscopy; Meniscus; Meniscectomy; Nanoscopic

Outcome Measures

Primary Outcomes (2)

• Functional Outcomes following partial meniscectomy: Knee Injury and Osteoarthritis Score

  We will be looking at functional outcomes following partial meniscectomy with the nanoscope compared to standard arthroscopy by looking at Knee Injury and Osteoarthritis Score (O -100 with higher being patients doing better functionally)

  6 weeks

• Functional Outcomes Following Partial Meniscectomy: International Knee Documentation Committee Score

  We will be looking at functional outcomes following partial meniscectomy with the nanoscope compared to standard arthroscopy by looking at the International Knee Documentation Committee Score (0-100 with higher being patients doing better functionally)

  6 weeks

Secondary Outcomes (3)

• Pain: Visual Analog Pain Score

  6 weeks

• Narcotic Medication Use

  24 hours

• Return to work

  6 weeks

Study Arms (2)

Nanoscopic Partial Meniscectomy

EXPERIMENTAL

This is the experimental group. patients will have a partial meniscectomy performed using the arthrex nanoscope

Procedure: Nanoscopic partial meniscectomy

Standard Partial Meniscectomy

ACTIVE COMPARATOR

Patients will have a partial meniscectomy performed using standard arthroscopic equipment which is the current gold standard

Procedure: Standard Partial Meniscectomy

Interventions

Nanoscopic partial meniscectomy PROCEDURE

Patients will have a partial meniscectomy performed using the arthrex nanoscope and it will be compared to partial meniscectomy performed using standard arthroscopic equipment

Nanoscopic Partial Meniscectomy

Standard Partial Meniscectomy PROCEDURE

Patients will have partial meniscectomy performed using standard arthroscopic equipment

Standard Partial Meniscectomy

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• MRI positive for meniscus tear
• More than 3mm of joint space on PA flexion weightbearing x rays
• Primary arthroscopy

You may not qualify if:

• Workers compensation
• Older than 60 years of age
• Revision surgeries

Sponsors & Collaborators

• Marshall University: lead
• Arthrex, Inc.: collaborator
• Medstar Health Research Institute: collaborator

Study Sites (2)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

ACTIVE NOT RECRUITING

Marshall Orthopaedics - Teays Valley

Scott Depot, West Virginia, 25560, United States

RECRUITING

Central Study Contacts

Shane Taylor

CONTACT

6094729212; taylorsh@marshall.edu

Chad Lavender

CONTACT

3045526514; doclav@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 16, 2022
• Study Start: December 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)