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
Northwell Health
100 participants
Dec 6, 2023
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
Inclusion Criteria7
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, over the age of 18, undergoing a meniscectomy or meniscus repair
- In good general health as evidenced by medical history
- Under 45th percentile BMI
- Willing to adhere to the study intervention regimenregimen.
- Kellgren-Lawrence grade 2 or less
Exclusion Criteria5
- Febrile illness within 3 months
- BMI over 40
- Treatment with another investigational drug or other intervention within 6 months
- Kellgren-Lawrence grade 3 or more or 4
- History of autoimmune disease, circulatory disease, or vascular disorder
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Interventions
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.
Generic sleeve used as a placebo. This placebo will have a similar feel, texture, and look with no additional technology.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06041321