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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
- Reparel Sleeve (device)
- Placebo Sleeve (device)
Sponsor: Northwell Health · Participants: 100 · Started: Dec 6, 2023
Contact the study team
- Nadia Baichoo, MA · Phone: 516-640-1765
- Summer Koepplin · Phone: 516-427-0340
Official record on ClinicalTrials.gov — NCT06041321
Locations in the U.S.
| New York | Orlin 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.