Meniscus TearNCT06041763
Bridge-Enhanced ACL Repair (BEAR) in Meniscus Repair
A study testing Meniscal Repair Procedure and BEAR Implant in people with Meniscus Tear, run by NYU Langone Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Meniscus Tear
- What is being tested?
- Meniscal Repair Procedure and BEAR Implant
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2024to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of meniscus injury indicated for isolated repair, without concomitant ligament reconstruction or repair, cartilage repair procedure, or osteotomy.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: Outcomes Following Meniscal Repair With the BEAR Implant: A Randomized Controlled 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.
- Conditions
- Meniscus Tear
- Being tested
- Meniscal Repair Procedure, BEAR Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meniscal Repair ProcedureProcedure or surgery
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.
BEAR ImplantDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Meniscal Repair Procedure; Device: BEAR Implant |
| 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. Receives: Procedure: Meniscal Repair Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Baseline, 1 Year Post-Procedure
Incidence of Repair Failure
Instances of failure of the meniscal repair.
Measured: Up to 1 Year Post-Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start20 Nov 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus TearStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillem Gonzalez-Lomas, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041763
- Sponsor's protocol ID
- 23-00813
- Status last verified
- Feb 2026
- First submitted
- 12 Sep 2023
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Following Meniscal Repair With the BEAR Implant: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06041763
- Acronym / sponsor ID
- 23-00813
- Conditions
- Meniscus Tear
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BEAR Implant | Experimental | Procedure: Meniscal Repair Procedure, Device: BEAR ImplantAdult patients with meniscus injury indicated for isolated meniscus repair. In the experimental group, the BEAR Implant will be utilized in the repair procedure. |
| Standard Repair | Active comparator | Procedure: Meniscal Repair Procedureadult 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 may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- History of meniscus injury indicated for isolated repair, without concomitant ligament reconstruction or repair, cartilage repair procedure, or osteotomy.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meniscal Repair ProcedureAll 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. | Procedure or surgery | BEAR Implant, Standard Repair |
| BEAR ImplantThe 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. | Device | BEAR Implant |
Primary outcome
Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score
Time frame: Baseline, 1 Year Post-Procedure
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).
Change in Lysholm Scale Score
Time frame: Baseline, 1 Year Post-Procedure
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.
Change in Visual Analogue Scale (VAS) Score
Time frame: Baseline, 1 Year Post-Procedure
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.
Incidence of Repair Failure
Time frame: Up to 1 Year Post-Procedure
Instances of failure of the meniscal repair.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillem Gonzalez-Lomas, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meniscal Repair Procedure and BEAR Implant in people with Meniscus Tear, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Trasatti (856-885-3259, Emma.trasatti@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score (time frame: Baseline, 1 Year Post-Procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.