Clinical trial Recruiting at 1 site Interventional Ages 18 to 89

Comparing a new bioactive sleeve to a placebo for pain relief after meniscus surgery

Official title: 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

Run by Northwell Health · NCT06041321 · Data updated 2026-11-12

This study is testing a new pain-relief sleeve after meniscus surgery to see if it helps patients recover better than a fake sleeve.

More Meniscus Tear trials

Quick facts

Study typeInterventional
Ages18 Years to 89 Years
SexAll
Enrollment100 (estimated)
SponsorNorthwell Health
Academic / other
Locations1 site (Woodbury, New York)
StatusRecruiting
StartedDecember 6, 2023
Main results expectedOctober 2027
Study endsOctober 2028
Registry record updatedOctober 2, 2026
Trial IDNCT06041321 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 years old, in good health, and scheduled for meniscectomy or meniscus repair with a BMI under the 45th percentile.

Probably not a fit

Patients with a BMI over 40, severe knee osteoarthritis, or a history of autoimmune or vascular diseases may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a novel bioactive sleeve designed to reduce pain and improve recovery outcomes after meniscus surgery. It is a blinded randomized prospective study involving approximately 100 patients who will be assigned to receive either the bioactive sleeve or a placebo sleeve that looks and feels similar. The study will assess various patient-reported outcomes and physical therapy metrics at multiple time points post-surgery to determine the sleeve's impact on healing and pain management.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management and faster recovery for patients undergoing meniscus surgery.

How similar studies have gone: While this approach is innovative, similar studies have shown promise in using bioactive materials for postoperative recovery, suggesting potential for success.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Orlin and Cohen Orthopedics
    Woodbury, New York, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.