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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BEAR Implant | Experimental | Adult patients with meniscus injury indicated for isolated meniscus repair. In the experimental group, the BEAR Implant will be utilized in the repair procedure. |
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| Standard Repair | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meniscal Repair Procedure | Procedure | All meniscal repairs will be performed by the surgeons who are listed as investigators for the study. Meniscal repair consists of arthroscopic suturing of torn fragments. This takes approximately 20 minutes. In the interventional group, the BEAR implant will be inserted through preexistent arthroscopic portals after repair is complete. This will take an additional 2 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score | 10-item assessment of knee-related symptoms at the present moment and over the previous 4 weeks. Each item is rated according to presence of symptoms. The raw score is the sum of responses and is rescaled to a total score ranging from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms). | Baseline, 1 Year Post-Procedure |
| Change in Lysholm Scale Score | 8-item assessment of knee-related activity and problems at the present moment. Each item is rated on a Likert-type scale. The total score is the sum of responses and ranges from 0 to 100, with higher scores indicating greater level of function/lower level of symptoms. | Baseline, 1 Year Post-Procedure |
| Change in Visual Analogue Scale (VAS) Score | One-item assessment of pain on the current day. Pain is rated on a scale from 0 (no pain) to 10 (worst possible, unbearable, excruciating pain); the total score is the numerical rating. | Baseline, 1 Year Post-Procedure |
| Incidence of Repair Failure | Instances of failure of the meniscal repair. | Up to 1 Year Post-Procedure |
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Inclusion Criteria:
• History of meniscus injury indicated for isolated repair, without concomitant ligament reconstruction or repair, cartilage repair procedure, or osteotomy.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emma Trasatti | Contact | 856-885-3259 | Emma.trasatti@nyulangone.org | |
| Samy Shelbaya | Contact | 517-575-5522 | samy.shelbaya@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Guillem Gonzalez-Lomas, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: isabel.wolfe@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to isabel.wolfe@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| BEAR Implant | Device | The BEAR Implant (22 mm in diameter and 45mm in length) is cylindrical in shape and comprised of collagen and extracellular matrix derived from bovine connective tissue, which has been cleaned, disinfected and processed by a proprietary manufacturing method. The implant has been terminally sterilized by electron-beam inadiation and is intended to be used with up to 10 ml of autologous blood drawn during the surgical implantation procedure. The BEAR Implant is resorbed within 8 weeks and replaced with a fibrovascular repair tissue. |
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