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
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:
• 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
Locations
United States
New York
Orlin and Cohen Orthopedics
RECRUITING
Woodbury
Contact Information
Primary
Nadia Baichoo, MA
nbaichoo@orlincohen.com
516-640-1765
Backup
Summer Koepplin
skoepplin@orlincohen.com
516-427-0340
Time Frame
Start Date: 2023-12-06
Estimated Completion Date: 2027-10
Participants
Target number of participants: 100
Treatments
Experimental: 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_comparator: 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
Related Therapeutic Areas
Sponsors
Collaborators: Reparel
Leads: Northwell Health