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Novel Bioactive Sleeve on Pain and PROMs

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

Who can join

Ages 18 to 89 · All sexes

Full 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

About the study

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.

What is being tested

Sponsor: Northwell Health · Participants: 100 · Started: Dec 6, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT06041321

Locations in the U.S.

New YorkOrlin and Cohen Orthopedics, Woodbury

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.