← Back to all trials
Recruiting
NCT06041321
Novel Bioactive Sleeve on Pain and PROMs
Conditions: Meniscus Tear
Sex: All
Ages: 18 Years – 89 Years
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Northwell Health
Location: Orlin and Cohen Orthopedics Woodbury New York
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 Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT06041321). StuddyBuddy aggregates publicly available trial information.