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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 89 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Northwell Health Academic / other |
| Locations | 1 site (Woodbury, New York) |
| Status | Recruiting |
| Started | December 6, 2023 |
| Main results expected | October 2027 |
| Study ends | October 2028 |
| Registry record updated | October 2, 2026 |
| Trial ID | NCT06041321 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
- Study coordinator: Puja Mishra, MS
- Email: pmishra2@orlincohen.com
- Phone: 516-615-0160
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Magic Angle Direction Imaging for ACL tears and meniscus injuries
This study tries a new low-field MRI technique called Magic Angle Direction Imaging to see if it shows ACL tears and meniscus injuries more clearly in adults scheduled for ligament repair.
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This test will see if walking on an anti-gravity treadmill helps adults 18–40 with MRI-confirmed meniscus tears reduce pain and improve knee function more than a conventional treadmill or standard rehab.
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This study is testing if using a special treatment called fibrin clots during surgery can help people with meniscus tears heal better than the usual repair methods.
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Effects of exercise on knee cartilage and function in people with meniscus tears
This study tests whether progressive resistance exercises or aerobic exercises can improve knee cartilage health and function in people aged 35-55 with meniscus tears.
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Assessment of meniscal root tears treated with suture to the posterior cruciate ligament
This study tests a new surgical method for fixing meniscal root tears in the knee to see if it helps patients recover better and avoid future problems like arthritis.
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Using a collagen implant to enhance meniscus repair in the knee
This study is testing if a special collagen implant can help people heal better after surgery for a torn meniscus in the knee compared to standard repair methods.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.