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Behavioural Intervention

Reparel Sleeve for Meniscus Tears

N/A
Recruiting
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, over the age of 18, undergoing a meniscectomy or meniscus repair
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will compare a new type of sleeve to a fake sleeve that looks and feels similar. They will look at how the sleeves affect pain levels, what patients say about their experience, and how well

Who is the study for?
This trial is for men and women over 18 who are having a meniscus tear surgery, in good health with a BMI in the lower 45th percentile. Participants must be willing to follow the study plan and be available throughout its duration. They should have mild to moderate knee arthritis (Kellgren-Lawrence grade 2 or less).Check my eligibility
What is being tested?
The study is testing a new bioactive sleeve against a placebo sleeve that looks similar but has no active treatment properties. The goal is to see if there's any difference in pain relief, improvement of knee function, and healing after meniscus surgery.See study design
What are the potential side effects?
Since this trial involves non-invasive sleeves, side effects may include skin irritation or discomfort at the site where the sleeve is worn. No significant systemic side effects are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 and having surgery on my knee's meniscus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Visual Analogue Scale (VAS) pain score
Secondary outcome measures
Range of Motion

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Reparel SleeveExperimental Treatment1 Intervention
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
Group II: Placebo SleevePlacebo Group1 Intervention
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

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
460 Previous Clinical Trials
470,943 Total Patients Enrolled
ReparelUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are they currently accepting participants for this research study?

"Indeed, according to the information available on clinicaltrials.gov, this study is currently seeking eligible participants. The initial posting of the study occurred on December 6th, 2023, and it was most recently updated on January 16th, 2024."

Answered by AI

Is it possible for me to participate in this research study?

"To be eligible for enrollment in this research study, potential participants must have a diagnosis of meniscus tears and fall within the age range of 18 to 89. The trial aims to recruit a total of 100 individuals who meet these criteria."

Answered by AI

What is the collective count of participants who are joining this medical research study?

"Indeed, the information provided on clinicaltrials.gov confirms that this trial is presently seeking eligible participants. The initial posting of the clinical trial took place on December 6th, 2023, and it was last modified on January 16th, 2024. The study aims to enroll a total of 100 individuals from a single location."

Answered by AI

Are individuals above the age of 18 eligible to participate in this clinical trial?

"As mentioned in the eligibility requirements for this research study, individuals must be at least 18 years of age and no older than 89 years."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Novel Bioactive Sleeve on Pain and PROMs
James Paci 2023. "Novel Bioactive Sleeve on Pain and PROMs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06041321.
~67 spots leftby Oct 2025
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