Reparel Sleeve for Meniscus Tear Pain

This study is looking at how well a special sleeve, called the Reparel Sleeve, works to reduce pain and improve recovery after surgery for a meniscus tear. It's being compared to a regular sleeve that looks and feels similar but doesn't have the special technology. The Reparel Sleeve has tiny semiconductors that are thought to reflect energy to help with healing. We're looking for about 100 people aged 18 to 89 who are having meniscus surgery. The main goal is to see if the Reparel Sleeve helps with pain, measured over two years, and improves how you feel and move after surgery. The study is currently unclear on its recruitment status.

Study design
This is a blinded randomized study, meaning you won't know if you're getting the Reparel Sleeve or the placebo sleeve, and neither will your doctors. About 100 people will participate.
What's involved
You would wear either the Reparel Sleeve or a placebo sleeve after your meniscus surgery. You'll also fill out questionnaires about your pain and recovery at several points over two years.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for two years after your surgery to assess your pain and recovery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06041321

Novel Bioactive Sleeve on Pain and PROMs

Recruiting
NAAges 18–89InterventionalBasic science
Northwell Health
~100 participants
Updated 2024-01-18 on ClinicalTrials.gov
What's tested:Reparel SleevePlacebo Sleeve

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Visual Analogue Scale (VAS) pain score
Measured over 2 years
Meniscus Tear

NCT06041321

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Orlin and Cohen Orthopedics

    Woodbury, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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Eligibility criteria

Inclusion

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

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
  • Visual Analogue Scale (VAS) pain score2 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').