Bridge-Enhanced ACL Repair (BEAR) in Meniscus Repair

Study Overview
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Brief Summary
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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.

Official Title
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Outcomes Following Meniscal Repair With the BEAR Implant: A Randomized Controlled Trial

Conditions
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Meniscus Tear

Intervention / Treatment
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* Procedure: Meniscal Repair Procedure
* Device: BEAR Implant


Participation Criteria
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Eligibility Criteria
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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: Patients who are undergoing meniscal repair for displaced bucket-handle meniscal tears Patients with a history of blood-borne diseases including HIV, hepatitis B virus, hepatitis C virus, human T-lymphotropic virus, and syphilis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BEAR Implant<br>Adult patients with meniscus injury indicated for isolated meniscus repair. In the experimental group, the BEAR Implant will be utilized in the repair procedure. | Procedure: Meniscal Repair Procedure<br>* 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.<br>Device: BEAR Implant<br>* 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.<br>|
| Active Comparator: Standard Repair<br>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. | Procedure: Meniscal Repair Procedure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |