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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
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.
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.
NYU Langone Health
New York, New York, United States
RECRUITINGChange 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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 1 Year Post-Procedure
Incidence of Repair Failure
Instances of failure of the meniscal repair.
Time frame: Up to 1 Year Post-Procedure
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