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Novel Bioactive Sleeve on Pain and PROMs
Sponsor: Northwell Health
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
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.
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