Bridge-Enhanced ACL Repair (BEAR) in Meniscus Repair
ConditionMeniscus Tear
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNYU Langone Health
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Meniscal Repair Procedure
Procedure/SurgeryAll 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.
BEAR Implant
DeviceThe 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: BEAR ImplantExperimental treatment 2 interventions
Group B: Standard RepairActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline, 1 Year Post-Procedure2
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-Procedure3
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-Procedure4
Incidence of Repair Failure
Instances of failure of the meniscal repair.
Time frame
Up to 1 Year Post-ProcedureSponsors and contacts
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Source ClinicalTrials.gov