Actively Recruiting
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
Led by Northwell Health · Updated on 2024-01-18
100
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
N
Northwell Health
Lead Sponsor
R
Reparel
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new bioactive leg sleeve called the Reparel Sleeve, comparing it to a placebo sleeve that looks and feels similar. This study aims to see if the Reparel Sleeve can reduce pain and improve patient-reported outcomes after partial arthroscopic meniscectomy or meniscus repair. The study will include about 100 patients and will assess pain, satisfaction, physical therapy time, and motor function over time. Participants will be randomly assigned to wear either the Reparel Sleeve, made from fabric embedded with a special nano-sized material designed to reflect energy and promote healing, or a generic black placebo sleeve without this technology. Both sleeves come in various sizes and have similar compression and feel. The study is blinded, meaning neither participants nor researchers know who is receiving which sleeve. Participants will complete questionnaires before surgery and at several time points afterward, including 1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years. Researchers will track pain using a visual scale, patient satisfaction, range of motion, and other outcome measures. The study will monitor progress and safety throughout the two-year follow-up period to evaluate the sleeves' effects on healing and pain control.
CONDITIONS
Brief Title
Novel Bioactive Sleeve on Pain and PROMs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and be available for the study duration
- Male or female, age 18 or older, scheduled for 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 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years following surgery
Participants receive either the novel bioactive Reparel Leg Sleeve or a placebo sleeve after their arthroscopic meniscectomy or meniscus repair surgery to assess effects on pain and recovery.
1 baseline visit and follow-up visits at 1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years post-surgery
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
S
Summer Koepplin
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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