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RECRUITING
NCT06041321
NA

Novel Bioactive Sleeve on Pain and PROMs

Sponsor: Northwell Health

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 89 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-12-06

Completion Date

2027-10

Last Updated

2024-01-18

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Reparel 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.

DEVICE

Placebo 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