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

Trial Summary

What is the purpose of 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.

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 data supports the effectiveness of the Reparel Sleeve treatment for meniscus tears?

The research suggests that using materials and biologic augmentation, like those potentially in the Reparel Sleeve, can help improve meniscus repair by supporting tissue healing and reducing the risk of repair failure. Techniques such as meniscal wrapping and scaffold implantation, which may be similar to the Reparel Sleeve, show promise in enhancing meniscal repair, although more studies are needed to confirm their effectiveness. ^{1 2 3 4 5}

What makes the Reparel Sleeve treatment for meniscus tears unique?

The Reparel Sleeve treatment is unique because it involves a novel bioactive sleeve designed to enhance the healing of meniscus tears, potentially offering a non-surgical option compared to traditional surgical repairs or meniscectomy. This approach may incorporate elements like extracellular matrix materials or polymer implants to support tissue regeneration, which is different from standard surgical methods. ^{1 4 5 6 7}

Eligibility Criteria

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.

I am over 18 and having surgery on my knee's meniscus.

Timeline

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

Treatment Details

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.

Participant Groups

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

Collaborator

Trials

1

Recruited

100+

Findings from Research

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Synthetic meniscus replacement: a review. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Meniscal Allograft Survivorship and Outcomes 20 Years After Implantation. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Meniscal repair: The current state and recent advances in augmentation. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Augmentation Techniques for Meniscus Repair. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Biologic Augmentation during Meniscal Repair. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Surgical options for meniscal replacement. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Complications after meniscal repair with bioabsorbable arrows: two cases and analysis of literature. [2016]