RECRUITING

Novel Bioactive Sleeve on Pain and PROMs

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-12-06
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06041321

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.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form
  2. * Stated willingness to comply with all study procedures and availability for the duration of the study
  3. * Male or female, over the age of 18, undergoing a meniscectomy or meniscus repair
  4. * In good general health as evidenced by medical history
  5. * Under 45th percentile BMI
  6. * Willing to adhere to the study intervention regimenregimen.
  7. * Kellgren-Lawrence grade 2 or less
  1. * Febrile illness within 3 months
  2. * BMI over 40
  3. * Treatment with another investigational drug or other intervention within 6 months
  4. * Kellgren-Lawrence grade 3 or more or 4
  5. * History of autoimmune disease, circulatory disease, or vascular disorder

Contacts and Locations

Study Contact

Nadia Baichoo, MA
CONTACT
516-640-1765
nbaichoo@orlincohen.com
Summer Koepplin
CONTACT
516-427-0340
skoepplin@orlincohen.com

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-06
Study Completion Date2027-10

Study Record Updates

Study Start Date2023-12-06
Study Completion Date2027-10

Terms related to this study

Additional Relevant MeSH Terms

  • Meniscus Tear