Outcomes of the Nanoscopic Partial Meniscectomy Versus Standard Arthroscopic Partial Meniscectomy

Meniscus Tear Clinical Trial

Official title:

Outcomes of the Nanoscopic Partial Meniscectomy Versus Standard Arthroscopic Partial Meniscectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05617807
• Other study ID #: 1926751-2
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Marshall University
• Contact: Shane Taylor
• Phone: 6094729212
• Email: taylorsh[@]marshall.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Meniscus Tear

Intervention

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
• Standard Partial Meniscectomy
Patients will have partial meniscectomy performed using standard arthroscopic equipment

Locations

Country	Name	City	State
United States	Marshall Orthopaedics - Teays Valley	Scott Depot	West Virginia
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Marshall University	Arthrex, Inc., Medstar Washington Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Pain: Visual Analog Pain Score	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)	6 weeks
Secondary	Narcotic Medication Use	we will be looking at the amount of narcotic pain medication used following nanoscopic partial meniscectomy compared to standard arthroscopy	24 hours
Secondary	Return to work	time to return to work following partial meniscectomy	6 weeks