Recruiting

Observational Study

Sponsor:

Northwell Health

Code:

NCT06041321

Conditions

Meniscus Tear

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Reparel Sleeve

Placebo Sleeve

Study Details

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

Study ID

NCT06041321

Start date

Dec 6, 2023

Status verified date

Sep, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Reparel Sleeve

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

placebo comparator: Placebo Sleeve

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

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.

Primary outcome measure

  • Visual Analogue Scale (VAS) pain score [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Puja Mishra, MS

516-615-0160pmishra2@orlincohen.com

Summer Koepplin

516-427-0340skoepplin@orlincohen.com

Locations

Orlin and Cohen Orthopedics

Recruiting

Woodbury, New York, United States, 11797

Contacts

Puja Mishra, MS

+1 (516)-615-0160pmishra2@orlincohen.com

Principal Investigator:

James Paci, MD

More Information

Sponsor

Northwell Health

Last update posted

Oct 2, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.