Novel Bioactive Sleeve on Pain and PROMs

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Meniscus Tear

Intervention / Treatment
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* Device: Reparel Sleeve
* Device: Placebo Sleeve


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a phase IV, parallel designed, placebo controlled, randomized clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reparel Sleeve<br>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<br>* 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.<br>|
| Placebo Comparator: Placebo Sleeve<br>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<br>* Generic sleeve used as a placebo. This placebo will have a similar feel, texture, and look with no additional technology.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS Pain Score | Assessing the effectiveness of a bioactive sleeve against a non-bioactive sleeve with regard to pain. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion | Assessing the effectiveness of a bioactive sleeve against a non-bioactive sleeve with regard to range of motion testing | 2 years |