RecruitingNot ApplicableNCT06041321

Novel Bioactive Sleeve on Pain and PROMs

The Effect of a Novel Bioactive Sleeve on Postoperative Pain and Patient Reported Outcome Scores After Arthroscopic Meniscectomy and Meniscus Repairs: A Randomized Placebo Controlled Study


Sponsor

Northwell Health

Enrollment

100 participants

Start Date

Dec 6, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

A novel bioactive sleeve will be compared to a placebo sleeve with a similar look and feel to assess pain outcomes, patient reported outcome measures, and effectiveness of healing based on range of motion.


Eligibility

Min Age: 18 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Placebo Sleeve and a medical device called Reparel Sleeve for people with meniscus tear. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 89 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEReparel Sleeve

For the purpose of this study, the Reparel Sleeve will be evaluated against a placebo sleeve of similar feel, texture, and look. The indication is that due to its technology, the Reparel sleeve will allow for the ability to reflect energy using a blend of semi-conductors grounded to nanoparticles interwoven between fibers of the sleeve. Thermal energy is then absorbed from the patient thus activating electrons on the nanoparticles and releasing photonic energy directed at tissues within the surrounding area7. This photostimulation is expected to alleviate pain and inflammation while promoting wound healing as well as tissue regeneration.

DEVICEPlacebo Sleeve

Generic sleeve used as a placebo. This placebo will have a similar feel, texture, and look with no additional technology.


Locations(1)

Orlin and Cohen Orthopedics

Woodbury, New York, United States

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NCT06041321


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