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NCT Number: NCT06041321

Novel Bioactive Sleeve on Pain and PROMs

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.

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Key information

Conditions

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orlin and Cohen Orthopedics

Woodbury, New York, 11797, United States

Location status: Recruiting

Location contact

James Paci, MD

PRINCIPAL_INVESTIGATOR

Nadia Baichoo, MA

CONTACT

[email protected]

About this study

This is a blinded randomized prospective study comparing two postoperative leg sleeves. The novel bioactive sleeve (Reparel Leg Sleeve) will be compared to a regular black sleeve with a similar feel/compression. The main hypothesis for this study is that postoperative use of a novel bioactive sleeve after partial arthroscopic meniscectomy/meniscus repair will decrease pain and improve patient reported outcome scores faster and more reliably than the control non-bioactive sleeve. In order to test this hypothesis, approximately 100 patients scheduled for meniscectomy/meniscus repair will be randomized to one of the two arms in order to minimize bias. The following variables will be assessed: patient reported outcomes (VAS, KOOS JR, VR12, and KSS Satisfaction), physical therapy time, motor testing. Each patient will fill out a series of PROMs preoperatively, and post operatively at the 1-week, 2-week, 6-week, 3-month, 6-month, 1 year, and 2-year mark.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebo Sleeve

Device

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

Primary outcomes

  1. Visual Analogue Scale (VAS) pain score

    Time frame: 2 years

    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').

Secondary outcomes

  1. Range of Motion

    Time frame: 2 years

    Assessing the effectiveness of a bioactive sleeve against a non-bioactive sleeve with regard to range of motion testing. Range of motion is calculated by degrees of flexion and extension of the knee.

Study contacts

Contact information is provided by the study sponsor or research team.

Nadia Baichoo, MA

CONTACT

[email protected]

516-640-1765

Summer Koepplin

CONTACT

[email protected]

516-427-0340

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Reparel

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Sep 18, 2023
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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