Novel Bioactive Sleeve on Pain and PROMs

Launched by NORTHWELL HEALTH · Sep 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new type of bioactive sleeve designed to help people with meniscus tears. The goal is to see if this sleeve can reduce pain and improve healing compared to a similar-looking placebo sleeve that doesn't have any active ingredients. Researchers will measure how much pain participants feel, how well they are doing overall, and how much they can move their knee after treatment.

To participate in this trial, you need to be at least 18 years old and undergoing surgery for a meniscus tear, either through removal or repair. You should be in good health and have a body mass index (BMI) below the 45th percentile. If you decide to join, you’ll need to agree to follow the study rules and attend all required visits. This trial is currently looking for volunteers, and it’s open to all genders. Participants will receive close monitoring and support throughout the study.

Gender

ALL

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