Novel Bioactive Sleeve on Pain and PROMs
- Conditions
- Meniscus Tear
- Interventions
- Device: Reparel SleeveDevice: Placebo Sleeve
- Registration Number
- NCT06041321
- Lead Sponsor
- Northwell Health
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Reparel Sleeve 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 Sleeve 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
- Primary Outcome Measures
Name Time Method Visual Analogue Scale (VAS) pain score 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 Outcome Measures
Name Time Method Range of Motion 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.
Trial Locations
- Locations (1)
Orlin and Cohen Orthopedics
馃嚭馃嚫Woodbury, New York, United States