Anterior Cruciate Ligament InjuryBEARNCT02292004
Bridge-Enhanced ACL Repair-Safety Study (BEAR Trial)
A study testing ACL Repair with MIACH Scaffold and Standard ACL Reconstruction in people with Anterior Cruciate Ligament Injury and Anterior Cruciate Ligament Tear, run by Miach Orthopaedics at 1 site in United States.
Trial summary
This study will assess the safety and early efficacy of a newly developed device, bridge-enhanced scaffold (MIACH™,) used to repair a torn anterior cruciate ligament (ACL.) Ten participants will undergo surgery with the new device (Experimental Group) and 10 will undergo a standard ACL reconstruction surgery (Control… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Tear
- What is being tested?
- ACL Repair with MIACH Scaffold and Standard ACL Reconstruction
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 31 Dec 2026
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Complete ACL tear, confirmed by MRI
- Time from injury to screening must be less than or equal to 90 days
- ACL tissue present on pre-operative MRI
Who cannot join
- Prior surgery on affected knee
- History of prior infection in affected knee
- Regular use of tobacco or nicotine in any form
- Use of corticosteroid within last 6 months
- Ever underwent chemotherapy treatment
- History of sickle cell disease
Show all 17Show fewer
- History of anaphylaxis
- Any condition that could affect healing (Diabetes, inflammatory arthritis, etc)
- Diagnosis of posterolateral corner injury (LCL complete tear, Biceps femoris tendon avulsion, tear of the arcuate ligament, tear of the popliteus ligament)
- Diagnosis of Grade III medial collateral ligament injury
- Diagnosis of complete patellar dislocation
- ACL deemed normal on arthroscopic inspection
- Time from injury to surgery is greater than 90 days (for Comparator group) and greater than 30 days (for Experimental group)
- Experimental Group: Less than 50 percent of ACL remaining
- Displaced bucket handle meniscal injury requiring repair
- Diagnosis of full-thickness chondral injury on either condyle
- Grade III medial collateral ligament injury
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Bridge-Enhanced ACL Repair-Safety Study
This study will assess the safety and early efficacy of a newly developed device, bridge-enhanced scaffold (MIACH™,) used to repair a torn anterior cruciate ligament (ACL.) Ten participants will undergo surgery with the new device (Experimental Group) and 10 will undergo a standard ACL reconstruction surgery (Control Group.)
Read the detailed description
This is a first-in-human trial for evaluation of the safety (Primary Objective) and short-term efficacy (Secondary Objective) of the MIACH™ ACL scaffold and will be carried out in form of an observational study of 20 patients: 10 experimental and 10 control.
- Being tested
- ACL Repair with MIACH Scaffold, Standard ACL Reconstruction
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL Repair with MIACH ScaffoldDevice
Surgical insertion of the MIACH scaffold to promote ACL healing/repair
Standard ACL ReconstructionProcedure or surgery
Standard surgical reconstruction of the ACL with autograft hamstring tendon
| Study group | Role | What they receive |
|---|---|---|
| ACL repair with MIACH scaffold | Experimental | Patients will undergo ACL repair surgery using the newly developed MIACH scaffold Receives: Device: ACL Repair with MIACH Scaffold |
| Standard ACL reconstruction | Active comparator | Patients will undergo a standard ACL reconstruction surgery Receives: Procedure: Standard ACL Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of the BEAR® Implant
To assess the safety (implant rejection, infection, joint effusion, muscle atrophy, knee laxity) and tolerability of the BEAR® implant
Measured: Surgery to 3-months post-op
Secondary outcomes (5)
Inflammatory reaction
Tense effusion limiting motion, fever or increased knee pain for more than three weeks after surgery and synovial fluid culture is negative for organisms.
Measured: Surgery to 3-months post-op
Muscle Atrophy
Patient cannot ambulate independently and continues to require crutches for ambulation for more than six weeks after surgery as a result of the muscle weakness. Patient report leg feels unstable ambulating without crutches at six weeks after surgery.
Measured: At 6-weeks post-op
Excessive Pain
Patient needs to be readmitted to the hospital for parenteral (IV or IM) pain medications but no other adverse event (e.g. infection or inflammation) is found.
Measured: Surgery to 3-months post-op
Implant failure
Lachman exam demonstrates 6mm or greater AP knee laxity when the knee is in 25 degrees of flexion in the operated knee than the unoperated knee on examination by the physician in the office. Both knees will be covered and the examining physician blinded to which knee was the surgical knee prior to the testing.
Measured: At 3-months post-op
Anteroposterior (AP) knee laxity
KT-1000 testing of AP laxity in both knees reveals a side-to-side difference of >=6mm when performed by the clinician. The knees will be covered and the examiner blinded as to which is the operated knee.
Measured: At 6- and 12-months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startJan 2015
- Primary completion19 Mar 2018
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miach Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis Kramer, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292004
- Sponsor's protocol ID
- IRB-P00012985
- Acronym
- BEAR
- Status last verified
- Dec 2025
- First submitted
- 12 Nov 2014
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Murray MM, Flutie BM, Kalish LA, Ecklund K, Fleming BC, Proffen BL, Micheli LJ. The Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) Procedure: An Early Feasibility Cohort Study. Orthop J Sports Med. 2016 Nov 21;4(11):2325967116672176. doi: 10.1177/2325967116672176. eCollection 2016 Nov.
PubMed 27900338Barnett SC, Murray MM, Flannery SW; BEAR Trial Team; Menghini D, Fleming BC, Kiapour AM, Proffen B, Sant N, Portilla G, Sanborn R, Freiberger C, Henderson R, Ecklund K, Yen YM, Kramer D, Micheli L. ACL Size, but Not Signal Intensity, Is Influenced by Sex, Body Size, and Knee Anatomy. Orthop J Sports Med. 2021 Dec 17;9(12):23259671211063836. doi: 10.1177/23259671211063836. eCollection 2021 Dec.
PubMed 34988237Kiapour AM, Ecklund K, Murray MM; BEAR Trial Team; Flutie B, Freiberger C, Henderson R, Kramer D, Micheli L, Thurber L, Yen YM, Fleming BC. Changes in Cross-sectional Area and Signal Intensity of Healing Anterior Cruciate Ligaments and Grafts in the First 2 Years After Surgery. Am J Sports Med. 2019 Jul;47(8):1831-1843. doi: 10.1177/0363546519850572. Epub 2019 Jun 5.
PubMed 31166701
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridge-Enhanced ACL Repair-Safety Study
- ClinicalTrials.gov ID
- NCT02292004
- Acronym / sponsor ID
- BEAR / IRB-P00012985
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Miach OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- Jan 2015 (actual)
- Primary completion
- 19 Mar 2018 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Nov 2014 (estimated)
- 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.
This study will assess the safety and early efficacy of a newly developed device, bridge-enhanced scaffold (MIACH™,) used to repair a torn anterior cruciate ligament (ACL.) Ten participants will undergo surgery with the new device (Experimental Group) and 10 will undergo a standard ACL reconstruction surgery (Control Group.)
Detailed description
This is a first-in-human trial for evaluation of the safety (Primary Objective) and short-term efficacy (Secondary Objective) of the MIACH™ ACL scaffold and will be carried out in form of an observational study of 20 patients: 10 experimental and 10 control.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACL repair with MIACH scaffold | Experimental | Device: ACL Repair with MIACH ScaffoldPatients will undergo ACL repair surgery using the newly developed MIACH scaffold |
| Standard ACL reconstruction | Active comparator | Procedure: Standard ACL ReconstructionPatients will undergo a standard ACL reconstruction surgery |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Complete ACL tear, confirmed by MRI
- Time from injury to screening must be less than or equal to 90 days
- ACL tissue present on pre-operative MRI
Key exclusion criteria (17 listed)
- Prior surgery on affected knee
- History of prior infection in affected knee
- Regular use of tobacco or nicotine in any form
- Use of corticosteroid within last 6 months
- Ever underwent chemotherapy treatment
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 |
|---|---|---|
| ACL Repair with MIACH ScaffoldSurgical insertion of the MIACH scaffold to promote ACL healing/repair | Device | ACL repair with MIACH scaffold |
| Standard ACL ReconstructionStandard surgical reconstruction of the ACL with autograft hamstring tendon | Procedure or surgery | Standard ACL reconstruction |
Primary outcome
Safety and tolerability of the BEAR® Implant
Time frame: Surgery to 3-months post-op
To assess the safety (implant rejection, infection, joint effusion, muscle atrophy, knee laxity) and tolerability of the BEAR® implant
5 secondary outcomes
Inflammatory reaction
Time frame: Surgery to 3-months post-op
Muscle Atrophy
Time frame: At 6-weeks post-op
Excessive Pain
Time frame: Surgery to 3-months post-op
Implant failure
Time frame: At 3-months post-op
Anteroposterior (AP) knee laxity
Time frame: At 6- and 12-months post-op
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 9 Jun 2026.
- Background: PubMed 27900338Murray MM, Flutie BM, Kalish LA, Ecklund K, Fleming BC, Proffen BL, Micheli LJ. The Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) Procedure: An Early Feasibility Cohort Study. Orthop J Sports Med. 2016 Nov 21;4(11):2325967116672176. doi: 10.1177/2325967116672176. eCollection 2016 Nov.
- Derived from this study: PubMed 34988237Barnett SC, Murray MM, Flannery SW; BEAR Trial Team; Menghini D, Fleming BC, Kiapour AM, Proffen B, Sant N, Portilla G, Sanborn R, Freiberger C, Henderson R, Ecklund K, Yen YM, Kramer D, Micheli L. ACL Size, but Not Signal Intensity, Is Influenced by Sex, Body Size, and Knee Anatomy. Orthop J Sports Med. 2021 Dec 17;9(12):23259671211063836. doi: 10.1177/23259671211063836. eCollection 2021 Dec.
- Derived from this study: PubMed 31166701Kiapour AM, Ecklund K, Murray MM; BEAR Trial Team; Flutie B, Freiberger C, Henderson R, Kramer D, Micheli L, Thurber L, Yen YM, Fleming BC. Changes in Cross-sectional Area and Signal Intensity of Healing Anterior Cruciate Ligaments and Grafts in the First 2 Years After Surgery. Am J Sports Med. 2019 Jul;47(8):1831-1843. doi: 10.1177/0363546519850572. Epub 2019 Jun 5.
- Individual participant dataSharing planned: No
Related trials for Anterior Cruciate Ligament Injury
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
RecruitingObservational study
Evaluation of the Correlation Between Bone Tunnel Projection Placement and Clinical Outcomes in Anterior Cruciate Ligament Reconstruction Surgery
Anterior Cruciate Ligament Injury, Tunneling Technique
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. This study is not recruiting at the moment.
Dennis Kramer, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACL Repair with MIACH Scaffold and Standard ACL Reconstruction in people with Anterior Cruciate Ligament Injury and Anterior Cruciate Ligament Tear, run by Miach Orthopaedics 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 3 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 9 Jun 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of the BEAR® Implant (time frame: Surgery to 3-months post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02292004, which also lists 3 linked publications.
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 9 Jun 2026.