Outcomes of the Nanoscopic Partial Meniscectomy Versus Standard Arthroscopic Partial Meniscectomy

NCT ID: NCT05617807

Last Updated: 2024-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Meniscus Tear

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nanoscopic Partial Meniscectomy

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

Group Type EXPERIMENTAL

Nanoscopic partial meniscectomy

Intervention Type 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

Standard Partial Meniscectomy

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

Group Type ACTIVE_COMPARATOR

Standard Partial Meniscectomy

Intervention Type PROCEDURE

Patients will have partial meniscectomy performed using standard arthroscopic equipment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

Standard Partial Meniscectomy

Patients will have partial meniscectomy performed using standard arthroscopic equipment

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Arthrex, Inc.

INDUSTRY

Sponsor Role collaborator

Medstar Health Research Institute

OTHER

Sponsor Role collaborator

Marshall University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shane Taylor

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

MedStar Washington Hospital Center

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

Site Status ACTIVE_NOT_RECRUITING

Marshall Orthopaedics - Teays Valley

Scott Depot, West Virginia, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Shane Taylor

Role: CONTACT

6094729212

Chad Lavender

Role: CONTACT

3045526514

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Chad Lavender

Role: primary

304-552-6514

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1926751-2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Efficacy and Safety of FF-31501 in Meniscus Tear Patients
NCT05777967 ACTIVE_NOT_RECRUITING PHASE3
Triathlon PSR Outcomes Study
NCT04618770 TERMINATED NA