Outcomes of the Nanoscopic Partial Meniscectomy Versus Standard Arthroscopic Partial Meniscectomy

Sponsor

Marshall University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05617807

Collaborator

Arthrex, Inc. (Industry), Medstar Washington Hospital Center (Other)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

49.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Meniscus Tear	Procedure: Nanoscopic partial meniscectomy Procedure: Standard Partial Meniscectomy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized Controlled TrialRandomized Controlled Trial

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Outcomes of the Nanoscopic Partial Meniscectomy Versus Standard Arthroscopic Partial Meniscectomy

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nanoscopic Partial Meniscectomy This is the experimental group. patients will have a partial meniscectomy performed using the arthrex nanoscope	Procedure: Nanoscopic partial meniscectomy Patients will have a partial meniscectomy performed using the arthrex nanoscope and it will be compared to partial meniscectomy performed using standard arthroscopic equipment
Active Comparator: Standard Partial Meniscectomy Patients will have a partial meniscectomy performed using standard arthroscopic equipment which is the current gold standard	Procedure: Standard Partial Meniscectomy Patients will have partial meniscectomy performed using standard arthroscopic equipment

Arm

Intervention/Treatment

Experimental: Nanoscopic Partial Meniscectomy

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

Procedure: Nanoscopic partial meniscectomy

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

Active Comparator: Standard Partial Meniscectomy

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

Procedure: Standard Partial Meniscectomy

Patients will have partial meniscectomy performed using standard arthroscopic equipment

Outcome Measures

Primary Outcome Measures

Functional Outcomes following partial meniscectomy: Knee Injury and Osteoarthritis Score [6 weeks]
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)
Functional Outcomes Following Partial Meniscectomy: International Knee Documentation Committee Score [6 weeks]
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)

Secondary Outcome Measures

Pain: Visual Analog Pain Score [6 weeks]
Pain following partial meniscectomy with the nanoscope compared to standard arthroscopy using Visual Analog Pain Score (0-10 with 0 being no pain and 10 being the worst pain)
Narcotic Medication Use [24 hours]
we will be looking at the amount of narcotic pain medication used following nanoscopic partial meniscectomy compared to standard arthroscopy
Return to work [6 weeks]
time to return to work following partial meniscectomy

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Workers compensation
Older than 60 years of age
Revision surgeries

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marshall Orthopaedics - Teays Valley	Scott Depot	West Virginia	United States	25560

Sponsors and Collaborators

Marshall University
Arthrex, Inc.
Medstar Washington Hospital Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shane Taylor, Principal Investigator, Marshall University

ClinicalTrials.gov Identifier:

NCT05617807

Other Study ID Numbers:

1926751-2

First Posted:

Nov 16, 2022

Last Update Posted:

Nov 23, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by Shane Taylor, Principal Investigator, Marshall University

Study Results

No Results Posted as of Nov 23, 2022