BEAR Scaffold vs ACL Reconstruction for ACL Tear

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Miach Orthopaedics

Must not be taking: Corticosteroids

Disqualifiers: Diabetes, Inflammatory arthritis, Sickle cell, others

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

Compensation: Varies

Number of Visits: 6

Duration: Surgery and immediate recovery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of two treatments for anterior cruciate ligament (ACL) tears. One treatment involves a tendon graft, where part of a tendon replaces the torn ACL. The other treatment, known as BEAR Scaffold, uses a special sponge placed between the torn ACL ends to facilitate regrowth. Individuals with a completely torn ACL who can undergo surgery within 45 days of injury may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for ACL tears.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used corticosteroids in the last 3 months.

What prior data suggests that the BEAR Scaffold and Tendon Graft are safe for ACL repair?

Research has shown that the BEAR Scaffold technique is generally well-tolerated. In one study, only 8.3% of patients required another surgery within a year, and 11.5% needed one by the study's end, which is quite low. Notably, there were no ACL retears after one year, and only 2.1% experienced a retear by the study's conclusion.

For the Tendon Graft method, no new safety information has emerged, but it remains a common procedure for ACL injuries. This method uses a tendon from another part of the body to replace the torn ACL and has been widely used, indicating it is generally safe.

Both methods have undergone research, and the BEAR Scaffold shows promising safety results. Participants considering joining a trial can feel reassured by these findings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BEAR Scaffold technique for ACL tears because it offers a unique approach compared to traditional surgery. Unlike the standard ACL reconstruction, which uses a tendon graft to replace the torn ligament, the BEAR Scaffold involves inserting a sponge-like scaffold between the torn ends of the ACL. This scaffold encourages the ligament to heal naturally by providing a structure for the tissue to regenerate. This method could potentially lead to more natural recovery and preservation of the original ACL structure, which is a promising advancement in knee injury treatments.

What evidence suggests that this trial's treatments could be effective for ACL tears?

This trial will compare the Bridge-Enhanced ACL Repair (BEAR) technique with the traditional ACL reconstruction method using a tendon graft. Research has shown that the BEAR technique can be as effective as the traditional method. Some studies indicate that BEAR results in similar recovery and knee function after surgery compared to the tendon graft method. Notably, BEAR has been associated with better hamstring strength two years post-surgery. Both treatments seem equally successful in restoring knee function over time. These findings suggest that BEAR could serve as a promising alternative to standard ACL reconstruction. ^{1 6 7 8 9}

Who Is on the Research Team?

Yi-Meng Yen, MD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

This trial is for males and females aged 14-35 with a complete ACL tear, who can have surgery within 45 days of injury. Participants must not have had previous knee surgeries or infections, use tobacco, or have conditions affecting healing like diabetes.

Inclusion Criteria

My gender does not affect my eligibility.

I am between 14 and 35 years old.

My MRI shows at least half of my ACL is still attached to the bone in my lower leg.

Exclusion Criteria

I have had surgery on my knee before.

I have undergone chemotherapy.

I have had an infection in my knee before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either the Bridge-Enhanced ACL Repair (BEAR) technique or ACL reconstruction

Surgery and immediate recovery

Follow-up

Participants are monitored for knee function and stability, with assessments at 6 months and 2 years post-surgery

2 years

Multiple visits for assessments at 6 months and 2 years

Long-term follow-up

Participants are monitored for long-term outcomes, including knee stability and function

10 years

What Are the Treatments Tested in This Trial?

Interventions

• BEAR Scaffold
• Tendon Graft

Trial Overview The study compares the BEAR technique—a new method to repair ACL tears using a special scaffold—with traditional tendon graft reconstruction. The goal is to see which treatment is more effective for repairing ACL injuries.

How Is the Trial Designed?

Group I: Bridge-Enhanced ACL Repair (BEAR) Experimental Treatment 1 Intervention

The BEAR technique involves surgically placing a sponge (the BEAR scaffold) between the torn ends of the ACL, providing a scaffold for the ligament ends to grow into.

Group II: Tendon Graft Active Control 1 Intervention

ACL reconstruction is when a tendon graft (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee) is taken and used to replace the torn ACL.

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/PMC11322937/

Bridge-Enhanced Anterior Cruciate Ligament Restoration This preliminary study suggests that the outcomes of BEAR and ACLR with a hamstring tendon graft may be similar at the 6-year follow-up.

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

Indications, Techniques, and Outcomes of Bridge-Enhanced ... Current research demonstrates similar postoperative patient-reported outcome measures and functional outcomes following BEAR compared to ACL ...

3. sicot-j.org sicot-j.org/articles/sicotj/full_html/2023/01/sicotj230014/sicotj230014.html

Bridge enhanced ACL repair vs. ACL reconstruction for ... The results showed that when compared to ACLR, BEAR had a significantly better hamstring strength 2 years postoperatively. (p < 0.00001, mean ...

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

Bridge-Enhanced ACL Repair vs ACL Reconstruction The BEAR technique involves surgically placing a sponge (the BEAR scaffold) between the torn ends of the ACL, providing a scaffold for the ligament ends to grow ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2212628722001906

Bridge-Enhanced Anterior Cruciate Ligament Repair for ... The subset of patients receiving BEAR who underwent a subsequent procedure had similar outcomes to those who underwent a single ACL reconstruction. The results ...

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

Postcommercialisation outcomes of bridge‐enhanced anterior ... Overall reoperation rate was 8.3% (8/96) at 1 year and 11.5% (11/96) at final follow-up, with 0% ACL retear at 1 year and 2.1% (2/96) ACL retear ...

8. miachortho.com miachortho.com/healthcare-professionals/clinical-evidence/

Clinical Evidence BEAR Implant patients experience a trend toward fewer contralateral ACL tears at 2 years. Contralateral ACL tears outcome data. Skier ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39143986/

6-Year Results From the First-in-Human Cohort Study - PubMed This preliminary study suggests that the outcomes of BEAR and ACLR with a hamstring tendon graft may be similar at the 6-year follow-up and ...