Novel Bioactive Sleeve on Pain and PROMs

Meniscus Tear Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06041321
• Other study ID #: 21-0250
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2023
• Est. completion date: October 2027

Study information

• Verified date: January 2024
• Source: Northwell Health
• Contact: Nadia Baichoo, MA
• Phone: 516-640-1765
• Email: nbaichoo[@]orlincohen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This is a blinded randomized prospective study comparing two postoperative leg sleeves. The novel bioactive sleeve (Reparel Leg Sleeve) will be compared to a regular black sleeve with a similar feel/compression. The main hypothesis for this study is that postoperative use of a novel bioactive sleeve after partial arthroscopic meniscectomy/meniscus repair will decrease pain and improve patient reported outcome scores faster and more reliably than the control non-bioactive sleeve. In order to test this hypothesis, approximately 100 patients scheduled for meniscectomy/meniscus repair will be randomized to one of the two arms in order to minimize bias. The following variables will be assessed: patient reported outcomes (VAS, KOOS JR, VR12, and KSS Satisfaction), physical therapy time, motor testing. Each patient will fill out a series of PROMs preoperatively, and post operatively at the 1-week, 2-week, 6-week, 3-month, 6-month, 1 year, and 2-year mark.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2027
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Meniscus Tear

Intervention

Device:
• Reparel Sleeve
For the purpose of this study, the Reparel Sleeve will be evaluated against a placebo sleeve of similar feel, texture, and look. The indication is that due to its technology, the Reparel sleeve will allow for the ability to reflect energy using a blend of semi-conductors grounded to nanoparticles interwoven between fibers of the sleeve. Thermal energy is then absorbed from the patient thus activating electrons on the nanoparticles and releasing photonic energy directed at tissues within the surrounding area7. This photostimulation is expected to alleviate pain and inflammation while promoting wound healing as well as tissue regeneration.
• Placebo Sleeve
Generic sleeve used as a placebo. This placebo will have a similar feel, texture, and look with no additional technology.

Locations

Country	Name	City	State
United States	Orlin and Cohen Orthopedics	Woodbury	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Reparel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS) pain score	Assessing the effectiveness of a bioactive sleeve against a non-bioactive sleeve with regard to pain. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').	2 years
Secondary	Range of Motion	Assessing the effectiveness of a bioactive sleeve against a non-bioactive sleeve with regard to range of motion testing. Range of motion is calculated by degrees of flexion and extension of the knee.	2 years