MIACH Scaffold for ACL Tear

(BEAR Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Miach Orthopaedics

Must not be taking: Corticosteroids

Disqualifiers: Tobacco use, Chemotherapy, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the MIACH scaffold, designed to help repair a torn anterior cruciate ligament (ACL), a key ligament in the knee. The researchers aim to determine if this new method is safe and as effective as the usual ACL reconstruction surgery. Participants will either undergo surgery with this new device or the standard surgery. Suitable candidates have a fully torn ACL confirmed by an MRI and have not had previous knee surgery. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future ACL repair techniques.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you use corticosteroids regularly, you may not be eligible to participate.

What prior data suggests that the MIACH scaffold is safe for ACL repair?

Research has shown that the MIACH scaffold, a new device for repairing a torn ACL, is generally well-tolerated by patients. In a study of the first 100 patients who used the device, no serious side effects related to the treatment were reported. Most patients experienced no major problems after surgery.

Early safety studies on this device also showed promising results. Patients who received the MIACH scaffold did not encounter more issues than those who underwent the usual ACL repair surgery. These findings suggest that the MIACH scaffold is safe for patients, appearing as safe as traditional ACL reconstruction surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for ACL tears, which typically involves reconstructing the ligament using a graft from another part of the body, the MIACH Scaffold offers a novel approach. This treatment uses a specially designed scaffold that supports the body's natural healing processes to regenerate the torn ligament itself. Researchers are excited because this method could lead to faster recovery times and potentially restore the knee more closely to its natural state, reducing long-term complications associated with traditional graft-based surgeries.

What evidence suggests that the MIACH scaffold is effective for ACL repair?

Research has shown that the MIACH scaffold, a special device, can help heal torn ACLs (anterior cruciate ligaments) by creating a new ligament similar to the traditional method. This approach not only repairs the ligament but also protects the joint after surgery. Early results suggest that the scaffold might effectively replace standard ACL reconstruction methods. In this trial, participants will either undergo ACL repair with the MIACH scaffold or receive standard ACL reconstruction. This scaffold is part of a new technique called Bridge-Enhanced ACL Repair. While traditional ACL repairs often fail, the MIACH scaffold shows promise in reducing these failures. ^{3 6 7 8 9}

Who Is on the Research Team?

Lyle Micheli, MD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with a complete ACL tear confirmed by MRI, and the injury must have occurred within the last 90 days. Participants should still have some ACL tissue visible on pre-operative MRI.

Inclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo ACL repair surgery using the MIACH scaffold or standard ACL reconstruction

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for safety and early efficacy, including inflammatory reactions, muscle atrophy, and excessive pain

3 months

Regular follow-up visits

Follow-up

Participants are monitored for long-term outcomes such as AP knee laxity

12 months

Follow-up visits at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• MIACH Scaffold

Trial Overview The study compares a new device called MIACH Scaffold used in repairing torn ACLs against standard ACL reconstruction surgery. It will involve 10 people getting the new treatment and another 10 receiving traditional surgery.

How Is the Trial Designed?

Group I: ACL repair with MIACH scaffold Experimental Treatment 1 Intervention

Patients will undergo ACL repair surgery using the newly developed MIACH scaffold

Group II: Standard ACL reconstruction Active Control 1 Intervention

Patients will undergo a standard ACL reconstruction surgery

Who Is Running the Clinical Trial?

Miach Orthopaedics

Lead Sponsor

Trials

5

Recruited

1,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3735821/

Use of a Bioactive Scaffold to Stimulate ACL Healing Also ... Bio-enhanced ACL repair produces a ligament that is biomechanically similar to an ACL graft and provides chondroprotection to the joint following ACL surgery.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11965036/

Indications, Techniques, and Outcomes of Bridge-Enhanced ... The current landscape of treating anterior cruciate ligament (ACL) tears is rapidly evolving with the advent of the bridge-enhanced ACL ...

3. withpower.com withpower.com/trial/phase-1-anterior-cruciate-ligament-injuries-2015-9763b

MIACH Scaffold for ACL Tear (BEAR Trial) 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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02664545

Bridge-Enhanced ACL Repair vs ACL Reconstruction The goal of this trial is to compare the efficacy of the Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR™) technique with the current method of ...

5. arthroscopytechniques.org arthroscopytechniques.org/article/S2212-6287(22)00190-6/fulltext

Bridge-Enhanced Anterior Cruciate Ligament Repair for ... However, failure rates as high as 50% were reported with primary repairs and led to the widespread adoption of ACL reconstruction with a tendon ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02292004

Bridge-Enhanced ACL Repair-Safety Study (BEAR Trial) 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6431773/

Bridge-Enhanced Anterior Cruciate Ligament Repair We recently completed a first-in-human safety study of a new ACL surgical alternative to ACLR in which suture repair is combined with a specific ...

8. esskajournals.onlinelibrary.wiley.com esskajournals.onlinelibrary.wiley.com/doi/10.1002/ksa.12806

Postcommercialisation outcomes of bridge‐enhanced anterior ... Purpose To review adverse events and outcomes at least 1 year postoperatively from Bridge enhanced ACL restoration (BEAR) in the first 100 ...

9. research.childrenshospital.org research.childrenshospital.org/researchers/martha-murray

Martha Murray, MD - Boston Children's Research Current data suggests that 76% of patients with an ACL tear will develop osteoarthritis at only 14 years from injury -- whether they have an ACL reconstruction ...