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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS) pain score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
The Biostatistics Unit will develop and implement the randomization procedure using the Biostatistics Randomization Management System (BRMS). The Biostatistics Randomization Management System (BRMS) is a secure, HIPAA-compliant, web-based application that allows investigators to randomize subjects into randomized clinical trials (RCTs) using their personal computer. The BRMS allows for multi-center, stratified, and single/double blinded RCTs, using permuted blocks. Randomization notifications (respectful of blinding status) are automatically sent to the PI and other authorized personnel. BRMS includes a feature that allows for medically indicated breaking of the blind, with requirement for justification. BRMS includes an audit trail of all transactions.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Reparel Sleeve (Device)
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
干预措施: Placebo Sleeve (Device)
结局指标
主要结局
Visual Analogue Scale (VAS) pain score
时间窗: 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').
次要结局
- Range of Motion(2 years)
研究者
James Paci
Principal Investigator
Northwell Health