Novel Bioactive Sleeve on Pain and PROMs

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

December 6, 2023

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2027

Conditions
Meniscus Tear
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.

Trial Locations (1)

11797

RECRUITING

Orlin and Cohen Orthopedics, Woodbury

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Reparel

UNKNOWN

lead

Northwell Health

OTHER