Novel Bioactive Sleeve on Pain and PROMs

Description

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.

Conditions

Meniscus Tear

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Study Overview

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Study Details

Study overview

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.

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

Novel Bioactive Sleeve on Pain and PROMs

Condition
Meniscus Tear
Intervention / Treatment

-

Contacts and Locations

Woodbury

Orlin and Cohen Orthopedics, Woodbury, New York, United States, 11797

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 89 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Northwell Health,

Study Record Dates

2027-10