Novel Bioactive Sleeve on Pain and PROMs

NCT06041321 | Recruiting FDA Device

• 1 other identifier: 21-0250
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Meniscus Tear

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS) pain score

  Assessing the effectiveness of a bioactive sleeve against a non-bioactive sleeve with regard to pain. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

  2 years

Secondary Outcomes (1)

• Range of Motion

  2 years

Study Arms (2)

Reparel Sleeve

EXPERIMENTAL

Device size(s): Small, medium, large, x-large Device model(s): Reparel Leg Sleeve (full length) Description of each component: Fabric garment constructed of 41% Polyester embedded with a proprietary non-metal semiconductive nano-sized material, 13% Polyester, 27% Nylon, and 19% Lycra-Spandex. The top cuff of the garment has silicone grips to keep the garment from sliding down. 501k exempt: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=FQL Company Name: Challenger Health, LLC (dba Reparel) FDA Registration Number: 3012651665 Device Listing Number: D269770 Product Classification: Class I Medical Device, 510(k) exempt Product Code: FQL, Stocking/Medical Support

Device: Reparel Sleeve

Placebo Sleeve

PLACEBO COMPARATOR

Device size(s): Small, medium, large, x-large Device model(s): Generic Black Leg Sleeve Supplier: Jupin Group Co., Ltd. Description of each component: Fabric garment constructed of 80% polyester and 20% lycra

Device: Placebo Sleeve

Interventions

Reparel Sleeve DEVICE

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.

Reparel Sleeve

Placebo Sleeve DEVICE

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

Placebo Sleeve

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• Reparel: collaborator

Study Sites (1)

Orlin and Cohen Orthopedics

Woodbury, New York, 11797, United States

RECRUITING

Central Study Contacts

Nadia Baichoo, MA

CONTACT

516-640-1765; nbaichoo@orlincohen.com

Summer Koepplin

CONTACT

516-427-0340; skoepplin@orlincohen.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The Biostatistics Unit will develop and implement the randomization procedure using the Biostatistics Randomization Management System (BRMS). The Biostatistics Randomization Management System (BRMS) is a secure, HIPAA-compliant, web-based application that allows investigators to randomize subjects into randomized clinical trials (RCTs) using their personal computer. The BRMS allows for multi-center, stratified, and single/double blinded RCTs, using permuted blocks. Randomization notifications (respectful of blinding status) are automatically sent to the PI and other authorized personnel. BRMS includes a feature that allows for medically indicated breaking of the blind, with requirement for justification. BRMS includes an audit trail of all transactions.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a phase IV, parallel designed, placebo controlled, randomized clinical trial

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 18, 2023
• Study Start: December 6, 2023
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2027
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)