BEAR Implant for Meniscus Tears

Overseen By Michael Moore

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Displaced meniscal tears, Blood-borne diseases

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The bridge-enhanced ACL repair (BEAR) implant is a collagen-based scaffold loaded with whole blood. It is designed to promote healing in the setting of intraarticular knee pathology. This study would compare clinical outcomes and synovial fluid cytokine profiles in patients who undergo isolated meniscal repair with or without the BEAR implant.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the BEAR Implant for Meniscus Tears treatment?

Research suggests that preserving the meniscus is important for knee function, and combining suture techniques with implants might be effective for certain meniscal tears. Additionally, biologic augmentation, like platelet-rich plasma, may reduce the risk of repair failure, indicating potential benefits for treatments like the BEAR Implant. ^{1 2 3 4 5}

Is the BEAR Implant for meniscus tears safe for humans?

The BEAR Implant, similar to other biodegradable implants used in meniscal repair, has been associated with some complications like chondral injury (damage to cartilage) and foreign-body reactions. However, these implants are generally considered reliable, though it's important to be aware of potential issues. ^{6 7 8 9 10}

How does the BEAR Implant treatment for meniscus tears differ from other treatments?

The BEAR Implant treatment for meniscus tears is unique because it involves the use of a biodegradable implant that helps repair the meniscus without requiring additional incisions, unlike some traditional methods. This approach aims to preserve more of the healthy meniscus tissue and potentially reduce complications associated with other biodegradable implants. ^{8 9 10 11 12}

Research Team

Guillem Gonzalez-Lomas, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for individuals with meniscus injuries that need repair but don't require other knee procedures like ligament reconstruction. Participants must not have blood-borne diseases such as HIV, hepatitis B or C, human T-lymphotropic virus, and syphilis.

Inclusion Criteria

I have a meniscus injury needing repair without other knee surgeries.

Exclusion Criteria

I am having surgery for a specific type of knee cartilage tear.

I have a history of blood-borne diseases like HIV or hepatitis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo isolated meniscal repair with or without the BEAR implant

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Multiple visits (in-person)

Treatment Details

Interventions

• Meniscal Repair Procedure
• Meniscal Repair Procedure with BEAR Implant

Trial Overview The study tests a new BEAR implant against standard meniscal repair procedures. The BEAR implant uses a collagen scaffold with the patient's own blood to encourage healing in the knee joint.

Participant Groups

Group I: BEAR Implant Experimental Treatment 2 Interventions

Adult patients with meniscus injury indicated for isolated meniscus repair. In the experimental group, the BEAR Implant will be utilized in the repair procedure.

Group II: Standard Repair Active Control 1 Intervention

adult patients with meniscus injury indicated for isolated meniscus repair. In the standard repair group, participants will undergo an isolated meniscus repair without the implant.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Findings from Research

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]

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

[Stage-based treatment by partial meniscectomy, meniscal refixation and transplantation]. [2016]

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

Meniscal Salvage: Where We Are Today. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Arthroscopic repair of bucket-handle tears of the lateral meniscus. [2022]

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

Factors Predicting Failure Rates and Patient-Reported Outcome Measures After Arthroscopic Meniscal Repair. [2020]

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

Biologic Augmentation during Meniscal Repair. [2023]

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

Arthroscopic meniscus repair with bioabsorbable arrows. [2019]

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

Evaluation of small intestinal submucosa grafts for meniscal regeneration in a clinically relevant posterior meniscectomy model in dogs. [2019]

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

Chondral injury after arthroscopic meniscal repair using bioabsorbable Mitek Rapidloc meniscal fixation. [2019]

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

Biomechanical investigations of different meniscal repair implants in comparison with horizontal sutures on human meniscus. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

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

11. Germany pubmed.ncbi.nlm.nih.gov

Measurement of meniscofemoral contact pressure after repair of bucket-handle tears with biodegradable implants. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

[Arthroscopic meniscus surgery]. [2022]