What side effects are associated with this type of intervention?

Common side effects of treatments for Anterior Cruciate Ligament (ACL) rupture, particularly those similar to the Bridge-Enhanced ACL Restoration (BEAR) procedure, include infection, graft rejection, and the need for further surgical procedures. Other potential side effects are inflammation, pain at the site of the implant, and complications related to the surgical procedure, such as bleeding or damage to surrounding tissues.

What prior FDA approvals exist?

There is limited information on FDA-approved treatments specifically similar to the Bridge-Enhanced ACL Restoration (BEAR) procedure, which uses an implant and the patient's own blood to stimulate ligament healing. Traditional FDA-approved treatments for ACL ruptures typically include surgical reconstruction using autografts or allografts, where tissue from the patient or a donor is used to replace the torn ligament. These methods do not involve the use of implants combined with biological augmentation like the BEAR procedure. Therefore, the BEAR procedure represents a novel approach in the treatment of ACL injuries.

What other types of research exist?

Promising novel alternatives to BEAR for ACL rupture treatment include: 1) Platelet-Rich Plasma (PRP) therapy, which involves injecting concentrated platelets to promote healing and reduce inflammation. 2) Stem cell therapy, utilizing mesenchymal stem cells to regenerate ligament tissue. 3) Gene therapy approaches, such as using viral vectors to deliver growth factors that enhance ligament repair. 4) Advanced scaffold materials, including bioengineered grafts that mimic natural ligament structure and promote tissue integration.

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Procedure

BEAR Procedure for ACL Injury

N/A

Waitlist Available

Research Sponsored by Miach Orthopaedics

Eligibility Criteria Checklist

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

Must have

At least 5% of the ACL attached to the tibia

Must not have

Use of chemotherapy

History of knee infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time points up to two years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new procedure called BEAR for treating ACL injuries. It uses an implant and the patient's blood to help heal the torn ligament. The study aims to see if age affects how well patients recover from this procedure. The BEAR technique combines repairing the ACL with a special material placed in the gap between the torn ends to help healing.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include infection risks around the implant site, possible graft rejection which could lead to additional surgeries, and general complications associated with surgical procedures.

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently using or have used chemotherapy.

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I have had a knee infection in the past.

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I have had surgery on my knee before.

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My BMI is over 35.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

International Knee Documentation Committee Objective Score (IKDC) (Physical Exam)

International Knee Documentation Committee Subjective Score (IKDC) (Survey)

Secondary study objectives

Knee Injury and Osteoarthritis Score (KOOS) questionnaire

Repair Failure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Bridge-Enhanced ACL Restoration (BEAR)Experimental Treatment1 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

0 / 5Eligibility 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 most common treatments for Anterior Cruciate Ligament (ACL) Rupture include surgical reconstruction using grafts and newer techniques like Bridge-Enhanced ACL Restoration (BEAR). Traditional ACL reconstruction involves replacing the torn ligament with a graft taken from the patient's own body (autograft) or from a donor (allograft). This graft acts as a scaffold for new ligament tissue to grow. The BEAR procedure, on the other hand, places an implant between the torn ends of the ACL and adds the patient's own blood to stimulate natural ligament healing. This method aims to preserve the original ACL tissue and promote more natural healing. These mechanisms are crucial for patients as they directly impact the recovery time, the strength and functionality of the healed ligament, and the overall success of the treatment in restoring knee stability and function.