What side effects are associated with this type of intervention?

The BEAR technique, which uses a blood-enriched implant to promote ACL healing, is associated with fewer invasive surgical requirements compared to traditional methods. Potential side effects may include infection, implant-related complications, and general surgical risks such as pain and swelling. The BPTB autograft reconstruction, which involves harvesting a segment of the patellar tendon, can lead to additional side effects such as anterior knee pain, patellar tendonitis, and a longer recovery period due to the more invasive nature of the procedure. Both techniques share common surgical risks like infection, blood clots, and knee stiffness.

What prior FDA approvals exist?

The BEAR (Bridge-Enhanced ACL Restoration) technique, which uses a blood-enriched implant to promote ACL reattachment and healing, is an FDA-approved treatment for ACL tears. This method contrasts with traditional ACL reconstruction techniques, such as the bone to patellar tendon to bone autograft (BPTB) reconstruction, which involves replacing the torn ACL with transplanted patellar tendon tissue. The BEAR technique aims to reduce the invasiveness of surgery and potentially mitigate long-term complications like premature osteoarthritis, although human data on this benefit are not yet available.

What other types of research exist?

One promising alternative to BEAR for ACL tear treatment is the use of allografts, which involve transplanting donor tissue. Another emerging technique is the use of synthetic grafts, such as the LARS (Ligament Advanced Reinforcement System) ligament, which aims to provide immediate stability and promote natural ligament regeneration. Additionally, advancements in stem cell therapy and tissue engineering are being explored to enhance ACL repair and regeneration.

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Procedure

BEAR Device vs. Autograft for ACL Tear (BEAR-MOON Trial)

N/A

Recruiting

Led By Kurt P Spindler, MD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Selected surgical treatment of ACL injury

18-55 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up kt-1000 instrumented knee laxity measure 2 years after surgery (difference from contralateral knee)

Awards & highlights

BEAR-MOON Trial Summary

This trial is designed to compare the effectiveness of two different surgical techniques for repairing a torn ACL. One technique, called BEAR, is new and involves placing a sponge between the torn ends of the ACL to provide a scaffold for the ligament to grow. The other technique, called BPTB, is the standard ACL surgery that replaces the torn portion of the ACL with transplanted patellar tendon tissue. The trial will conclude before any long-term benefits can be observed.

Who is the study for?

This trial is for individuals aged 18-55 who have a complete ACL tear confirmed by MRI and are within 50 days of their injury. They must be considered candidates for ACL surgery, agree to follow study procedures including activity restrictions, and provide informed consent.Check my eligibility

What is being tested?

The study compares two surgical techniques for repairing torn ACLs: the new BEAR method using a blood-enriched implant to promote healing, versus the traditional BPTB reconstruction that uses transplanted patellar tendon tissue.See study design

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include pain at the surgery site, infection risk from surgery, knee stiffness or weakness during recovery. The BEAR method aims to reduce invasive surgery burden.

BEAR-MOON Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have chosen surgery for my ACL injury.

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I am between 18 and 55 years old.

BEAR-MOON Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ validated patient reported koos subjective score instrument 2 years after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~validated patient reported koos subjective score instrument 2 years after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and validated patient reported koos subjective score instrument 2 years after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

IKDC (International Knee Documentation Committee) Score

KT-1000

Secondary outcome measures

Active Knee Range of Motion

Knee

Hop Test Limb Difference

+6 more

BEAR-MOON Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Bridge Enhanced ACL RestorationExperimental Treatment1 Intervention

Procedure/Surgery Bridge Enhanced ACL Restoration (BEAR): The surgical repair of the ACL using the BEAR technique involves surgically placing a sponge (the BEAR implant) between the torn ends of the ACL, providing a sponge for the ligament ends to group into.

Group II: ACL Reconstruction(BPTB Graft)Active Control1 Intervention

Procedure/Surgery ACL Reconstruction (Bone Patellar Tendon Bone Graft): Standard of care surgical procedure Patellar Tendon Autograft ACL reconstruction, in which a bone-patellar tendon-bone graft from the front of the knee is taken to replace the torn ACL.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The BEAR technique for treating ACL tears involves placing a blood-enriched sponge between the torn ends of the ACL to promote natural healing and reattachment, leveraging the body's own healing processes. This method is less invasive compared to the standard Bone-Patellar Tendon-Bone (BPTB) reconstruction, which replaces the torn ACL with a graft from the patient's patellar tendon, requiring additional surgery to harvest the graft. Understanding these mechanisms is important for patients as it highlights differences in surgical invasiveness, recovery times, and potential long-term outcomes, such as the risk of osteoarthritis.