Meniscus Tear
Conditions
Brief 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.
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
DEVICEReparel 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.
DEVICEPlacebo Sleeve
Generic sleeve used as a placebo. This placebo will have a similar feel, texture, and look with no additional technology.
Sponsors
Reparel
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
The Biostatistics Unit will develop and implement the randomization procedure using the Biostatistics Randomization Management System (BRMS). The Biostatistics Randomization Management System (BRMS) is a secure, HIPAA-compliant, web-based application that allows investigators to randomize subjects into randomized clinical trials (RCTs) using their personal computer. The BRMS allows for multi-center, stratified, and single/double blinded RCTs, using permuted blocks. Randomization notifications (respectful of blinding status) are automatically sent to the PI and other authorized personnel. BRMS includes a feature that allows for medically indicated breaking of the blind, with requirement for justification. BRMS includes an audit trail of all transactions.
Intervention model description
This is a phase IV, parallel designed, placebo controlled, randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) pain score | 2 years | 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'). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion | 2 years | 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. |
Countries
United States
Contacts
Primary ContactNadia Baichoo, MA
Backup ContactSummer Koepplin
Outcome results
None listed