Novel Bioactive Sleeve on Pain and PROMs

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Meniscus Tear

In brief

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.

Key facts

Study ID

NCT06041321

Run by

Northwell Health

People needed

100

Starts

2023-12-06

Expected to finish

2027-10-01

Last updated by the study team

2024-01-18

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Orlin and Cohen Orthopedics — Woodbury, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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