BEAR Procedure for ACL Injury

Not currently recruiting at 13 trial locations

Overseen By Beth Trainor, BSN

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Miach Orthopaedics

Must not be taking: Corticosteroids, Chemotherapy

Disqualifiers: Prior knee surgery, Tobacco, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Surgical procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new procedure called Bridge-Enhanced ACL Restoration (BEAR) to heal torn ACLs (a key ligament in the knee) using an implant and the patient's blood. The researchers aim to determine how age affects recovery with this treatment by comparing outcomes between older and younger patients. They are also monitoring for safety issues, such as infections or the need for additional surgery. This trial may suit individuals who recently injured their ACL within the last 50 days and still have a small part attached to the bone. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research and potentially benefit from an innovative treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes people using corticosteroids or undergoing chemotherapy.

What prior data suggests that the BEAR procedure is safe for ACL injury treatment?

Research has shown that the BEAR procedure for ACL injuries is generally well-tolerated. One study found that only 8.3% of patients required another surgery within a year, increasing to 11.5% by the final follow-up. Notably, no ACL tears occurred in the first year, and only 2.1% experienced a tear later. These findings suggest that the BEAR procedure may be safe, with few complications like re-injury. However, as with any medical procedure, risks such as infection or the need for additional surgery should be considered. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Bridge-Enhanced ACL Restoration (BEAR) procedure is unique because it offers a new approach to repairing ACL injuries by using an absorbable implant as a scaffold. Most current treatments for ACL injuries involve grafting, where a piece of tendon is taken from another part of the body or a donor to reconstruct the ligament. Unlike these grafts, the BEAR technique encourages the body to heal the torn ACL itself by bridging the gap between the torn ends, potentially leading to a more natural recovery. Researchers are excited about this method because it could reduce the risk of complications associated with grafts and promote a more natural healing process.

What evidence suggests that the BEAR procedure is effective for ACL injuries?

Research shows that the Bridge-Enhanced ACL Restoration (BEAR) procedure, which participants in this trial will undergo, holds promise for treating ACL injuries. Studies have found that BEAR can achieve results similar to traditional ACL surgery, with some patients experiencing better hamstring strength two years post-procedure. Additionally, BEAR patients often sustain fewer injuries to the opposite ACL within two years after surgery. This method uses a special implant and the patient's blood to aid in more effective healing of the torn ligament. Evidence suggests that BEAR serves as a good alternative to traditional ACL repair methods. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

The BEAR III Trial is for individuals who have recently (within 50 days) injured their ACL and still have at least 5% of the ligament attached to the tibia. It's not suitable for those with allergies to bovine products or gelatin, a BMI over 35, history of knee issues like infections or moderate osteoarthritis, prior knee surgery, tobacco use, or severe allergic reactions.

Inclusion Criteria

At least 5% of my ACL is attached to my shinbone.

ACL tear within 50 days of injury

Exclusion Criteria

I am currently using or have used chemotherapy.

I have had a knee infection in the past.

Use of tobacco

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Bridge-Enhanced ACL Restoration (BEAR) procedure, where an implant is placed between the torn ends of the ACL to stimulate healing

Surgical procedure

Follow-up

Participants are monitored for safety and effectiveness, including knee stability and function, up to two years after surgery

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Bridge-Enhanced ACL Restoration (BEAR)

Trial Overview This trial tests the BEAR procedure where an implant soaked in the patient's blood aims to heal torn ACLs. The study focuses on whether age affects recovery by comparing outcomes using scores that measure knee function two years post-surgery.

How Is the Trial Designed?

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

The BEAR technique involves surgically placing an absorbable implant (the BEAR Implant) between the torn ends of the ACL, providing a scaffold for the ligament ends to grow into

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. 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 ...

4. 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 ...

5. journaloei.scholasticahq.com journaloei.scholasticahq.com/article/38392-for-your-consideration-bridge-enhanced-acl-restoration-bear-why-how-and-when

"About The Innovation...Bridge Enhanced ACL Restoration ... In a meta-analysis performed by Ellis et al, allograft failure rates were noted to be 25% compared to 8.5% and 16.6% for bone-patella-tendon- ...

6. 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 ...

7. 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 ...