Novel Bioactive Sleeve on Pain and PROMs

ConditionMeniscus Tear

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-89

SponsorNorthwell Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Reparel Sleeve
Device
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
Device
Generic sleeve used as a placebo. This placebo will have a similar feel, texture, and look with no additional technology.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Reparel SleeveExperimental treatment 1 intervention

Group B: Placebo SleevePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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').

Time frame

2 years

Secondary outcomes

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.

Time frame

2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwell Health

Lead sponsor

Reparel

Collaborator

Source ClinicalTrials.gov

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