Reparel Sleeve for Meniscus Tears

Overseen By Summer Koepplin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Febrile illness, BMI over 40, others

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of sleeve to determine if it can reduce pain and aid in healing meniscus tears in the knee. Participants will wear either a special bioactive sleeve (Reparel Sleeve) or a regular sleeve that looks similar. Researchers will compare the effectiveness of each sleeve in terms of pain relief and knee movement. The trial seeks individuals undergoing surgery to repair a meniscus tear, who are generally healthy, and have a BMI under 40. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance knee recovery options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Reparel Sleeve is safe for meniscus tears?

Research shows that the Reparel Sleeve, a special type of sleeve, has been tested in people with knee osteoarthritis (OA). These studies suggest it might help reduce pain and improve symptoms and movement. No major safety issues emerged in these studies. The sleeve consists of materials like polyester and spandex and includes a unique tiny material.

The FDA classifies the Reparel Sleeve as a Class I medical device, indicating it's generally low risk. It's also 510(k) exempt, meaning it doesn't need a detailed review because it's similar to other products already available. This status suggests it's safe and well-tolerated. However, more research is needed to confirm these findings specifically for meniscus tears. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for meniscus tears involve rest, physical therapy, or surgery. However, the Reparel Sleeve stands out because it's a non-invasive, wearable device designed to enhance recovery. The sleeve is made from a unique fabric embedded with a proprietary non-metal semiconductive nano-sized material, which could promote healing by improving circulation and reducing inflammation. Researchers are excited about its potential to offer a convenient and effective alternative to more invasive procedures, potentially speeding up recovery while minimizing discomfort.

What evidence suggests that the Reparel Sleeve is effective for meniscus tears?

Research shows that bioactive sleeves, such as the Reparel Sleeve, may help reduce pain and improve movement in various conditions. One study found that similar sleeves significantly improved symptoms for people with Achilles tendinopathy, which causes pain and swelling in the Achilles tendon. Another study suggested that these sleeves could lessen pain and enhance movement for those with knee osteoarthritis, a common joint disease. These findings suggest that the Reparel Sleeve might also effectively aid meniscus tears by relieving pain and improving range of motion. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for men and women over 18 who are having a meniscus tear surgery, in good health with a BMI in the lower 45th percentile. Participants must be willing to follow the study plan and be available throughout its duration. They should have mild to moderate knee arthritis (Kellgren-Lawrence grade 2 or less).

Inclusion Criteria

Your Body Mass Index (BMI) is below the 45th percentile.

Your medical records demonstrate that you are in good physical condition.

You have signed and dated a consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the novel bioactive sleeve or a placebo sleeve postoperatively after meniscectomy/meniscus repair

6 weeks

1 visit (in-person) at 1-week, 2-week, and 6-week mark

Follow-up

Participants are monitored for pain outcomes and range of motion at various intervals

2 years

Visits at 3-month, 6-month, 1-year, and 2-year mark

What Are the Treatments Tested in This Trial?

Interventions

• Novel Bioactive Sleeve
• Placebo Sleeve

Trial Overview The study is testing a new bioactive sleeve against a placebo sleeve that looks similar but has no active treatment properties. The goal is to see if there's any difference in pain relief, improvement of knee function, and healing after meniscus surgery.

How Is the Trial Designed?

Group I: Reparel Sleeve Experimental Treatment 1 Intervention

Device size(s): Small, medium, large, x-large Device model(s): Reparel Leg Sleeve (full length) Description of each component: Fabric garment constructed of 41% Polyester embedded with a proprietary non-metal semiconductive nano-sized material, 13% Polyester, 27% Nylon, and 19% Lycra-Spandex. The top cuff of the garment has silicone grips to keep the garment from sliding down. 501k exempt: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=FQL Company Name: Challenger Health, LLC (dba Reparel) FDA Registration Number: 3012651665 Device Listing Number: D269770 Product Classification: Class I Medical Device, 510(k) exempt Product Code: FQL, Stocking/Medical Support

Group II: Placebo Sleeve Placebo Group 1 Intervention

Device size(s): Small, medium, large, x-large Device model(s): Generic Black Leg Sleeve Supplier: Jupin Group Co., Ltd. Description of each component: Fabric garment constructed of 80% polyester and 20% lycra

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Reparel

Industry Sponsor

Reparel

Collaborator

Trials

1

Recruited

100+

Published Research Related to This Trial

Synthetic meniscal substitutes are emerging as alternatives to meniscectomy for treating irreparable meniscal lesions, with two types available: porous, resorbable implants that promote tissue regeneration and solid, non-resorbable implants that permanently replace the meniscus.

While porous meniscus replacements show promise in improving clinical outcomes, their effectiveness compared to partial meniscectomy has yet to be established, highlighting the need for rigorous randomized controlled trials to validate their clinical performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthetic meniscus replacement: a review. Vrancken, AC., Buma, P., van Tienen, TG.[2021]

The shift from meniscectomy to meniscal repair aims to preserve joint health, but current repair techniques can be challenging and often ineffective, highlighting the need for improved methods.

Innovative approaches, including biologic augmentation and novel materials, are being developed to enhance meniscal healing by promoting cellular incorporation, vascularization, and mechanical integrity, which may lead to better long-term outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meniscal repair: The current state and recent advances in augmentation. Bansal, S., Floyd, ER., A Kowalski, M., et al.[2021]

Meniscal repair is primarily recommended for unstable, peripheral vertical tears, while other types of meniscal tears are often treated with partial meniscectomy due to biological and technical challenges.

Meniscal allograft transplantation has shown good long-term outcomes, but the long-term benefits for joint protection are still being studied, and several synthetic implants are being explored, although none are currently FDA-approved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical options for meniscal replacement. Brophy, RH., Matava, MJ.[2022]

Biodegradable implants for meniscal repair, introduced in the 1990s, have been used since 1999, but there are documented cases of failure, including a foreign-body reaction and a new meniscus tear after trauma.

While meniscus refixation with bioabsorbable arrows is generally considered reliable, the potential for complications, such as granuloma formation and additional tears, should be carefully considered by clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications after meniscal repair with bioabsorbable arrows: two cases and analysis of literature. Otte, S., Klinger, HM., Beyer, J., et al.[2016]

Meniscus tears, particularly in the vascularized outer zone, have a better chance of healing, leading to a shift in treatment from meniscectomy to repair methods that aim to preserve the meniscus and prevent osteoarthritis.

Innovative biological augmentation techniques, such as using growth factors and blood components, are being developed to enhance the healing process of meniscus repairs, showing promise in both preclinical and clinical studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmentation Techniques for Meniscus Repair. Ghazi Zadeh, L., Chevrier, A., Farr, J., et al.[2018]

Biologic augmentation techniques, particularly platelet-rich plasma (PRP) and bone marrow stimulation, may reduce the risk of failure in isolated meniscal repairs, although they do not significantly improve knee symptom scores.

Current evidence is limited regarding the effectiveness of various augmentation methods, with fibrin clot techniques lacking sufficient support for reducing failure risk, while meniscal wrapping and scaffold implantation show promise for complex tears but require further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biologic Augmentation during Meniscal Repair. Blough, CL., Bobba, CM., DiBartola, AC., et al.[2023]

After 20 years, meniscal allografts showed a survivorship rate of 56.2%, indicating that while they are not as durable as natural menisci, they can still provide long-term benefits.

Among the 48 patients surveyed, most reported subjective improvement in knee function, with only one patient expressing regret about undergoing the procedure, suggesting that meniscal allografts can enhance quality of life even years after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meniscal Allograft Survivorship and Outcomes 20 Years After Implantation. Carter, TR., Brown, MJ.[2021]

Citations

1. withpower.com withpower.com/trial/phase-meniscus-tears-9-2023-7c99f

Reparel Sleeve for Meniscus Tears 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 ...

2. journaloei.scholasticahq.com journaloei.scholasticahq.com/article/121294-investigating-the-efficacy-of-bioactive-sleeves-with-embedded-nano-semiconductors-in-alleviating-tendinopathy-an-in-vivo-pilot-study

Investigating the Efficacy of Bioactive Sleeves with Embedded ... The results of our study indicate that application of bioactive nano-semiconductor sleeves had a significant effect in alleviating Achilles tendinopathy.

3. momayamd.com momayamd.com/pdf/bioactive-knee-sleeve-for-osteoarthritis-updated.pdf

Bioactive Knee Sleeve for Osteoarthritis: A Small Cohort ... Conclusions: These data suggest that a bioactive sleeve may improve patient-reported pain, symptoms, and function in the setting of knee. OA. Further research ...

4. ctv.veeva.com ctv.veeva.com/study/novel-bioactive-sleeve-on-pain-and-proms

Novel Bioactive Sleeve on Pain and PROMs This is a blinded randomized prospective study comparing two postoperative leg sleeves. The novel bioactive sleeve (Reparel Leg Sleeve) will ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04751942?term=AREA%5BConditionSearch%5D(Knee)&rank=10

Reparel Knee Sleeve vs. TED Hose for Post-op Swelling, ... Despite its achievements, up to 25% of patients remain dissatisfied after the procedure due to lingering pain, amongst other complaints. Post-operative swelling ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36191914/

Bioactive Knee Sleeve for Osteoarthritis: A Small Cohort ... Conclusions: These data suggest that a bioactive sleeve may improve patient-reported pain, symptoms, and function in the setting of knee OA. Further research is ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04743921

Effects of Reparel™ Knee Sleeve on Knee Osteoarthritis The purpose of this study is to determine the clinical effects of Reparel™ knee sleeve regarding mobility, functionality, and pain outcomes in managing knee OA.

8. reparel.com reparel.com/

Reparel – Clinically Proven Recovery Sleeves for Arthritis ... Discover Reparel's advanced recovery sleeves. Reduce arthritis pain, swelling, and post-op inflammation with clinically validated, non-pharma comfort.