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Recruiting NCT06041321

Novel Bioactive Sleeve on Pain and PROMs

No phase Interventional Meniscus Tear

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Reparel Sleeve, Placebo Sleeve.
Who it may be relevant to
Registry conditions: Meniscus Tear. Basic parameters: 18 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

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.

Detailed 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.

Interventions

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

Primary outcome measures

  • Visual Analogue Scale (VAS) pain score [Time frame: 2 years]
Secondary outcome measures (1)
  • Range of Motion [Time frame: 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Orlin and Cohen Orthopedics — Woodbury

Identifiers

NCT: NCT06041321 · 21-0250

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗