Actively Recruiting
Novel Bioactive Sleeve on Pain and PROMs
Led by Northwell Health · Updated on 2024-01-18
100
Participants Needed
1
Research Sites
199 weeks
Total Duration
On this page
Sponsors
N
Northwell Health
Lead Sponsor
R
Reparel
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Novel Bioactive Sleeve on Pain and PROMs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form provided
- Willingness to comply with all study procedures and availability for the study duration
- Male or female aged over 18 years undergoing meniscectomy or meniscus repair
- In good general health based on medical history
- Body mass index (BMI) under the 45th percentile
- Willing to follow the study intervention regimen
- Kellgren-Lawrence grade 2 or less
You will not qualify if you...
- Febrile illness within the past 3 months
- Body mass index (BMI) over 40
- Treatment with another investigational drug or intervention within the past 6 months
- Kellgren-Lawrence grade 3 or 4
- History of autoimmune disease, circulatory disease, or vascular disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Orlin and Cohen Orthopedics
Woodbury, New York, United States, 11797
Actively Recruiting
Research Team
N
Nadia Baichoo, MA
CONTACT
S
Summer Koepplin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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