Comparing a new bioactive sleeve to a placebo for pain relief after meniscus surgery
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
NA · Northwell Health · NCT06041321
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Northwell Health (other) |
| Locations | 1 site (Woodbury, New York) |
| Trial ID | NCT06041321 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While this approach is innovative, similar studies have shown promise in using bioactive materials for postoperative recovery, suggesting potential for success.
Eligibility criteria
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 this trial is running
Woodbury, New York
- Orlin and Cohen Orthopedics — Woodbury, New York, United States (RECRUITING)
Study contacts
- Study coordinator: Nadia Baichoo, MA
- Email: nbaichoo@orlincohen.com
- Phone: 516-640-1765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Meniscus Tear