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Device

BEAR Scaffold vs ACL Reconstruction for ACL Tear

N/A

Waitlist Available

Led By Dennis Krammer, MD

Research Sponsored by Miach Orthopaedics

Eligibility Criteria Checklist

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

Must have

Age: 14 to 35 years of age.

MRI: ACL tissue present on pre-operative MRI - at least 50% of the ACL length must still be attached to the tibial plateau

Must not have

Prior surgery on affected knee

History of chemotherapy treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years after surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing two methods of treatment for ACL injuries. The first is the BEAR™ technique, which is a new method. The second is the current ACL reconstruction method.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include pain at the surgical site, swelling, infection risk, stiffness in the knee joint, and possible allergic reactions to materials used in either procedure.

Eligibility Criteria

Inclusion Criteria

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

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I am between 14 and 35 years old.

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

Exclusion Criteria

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

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I have had surgery on my knee before.

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I have undergone chemotherapy.

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I have had an infection in my knee before.

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I have used corticosteroids in the last 3 months.

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I have a severe knee injury involving specific ligaments and tendons.

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I have a history of sickle cell disease.

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I have a severe injury to the ligament on the inside of my knee.

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My kneecap has been completely dislocated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years after surgery for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Instrumented Anteroposterior (AP) Laxity Testing

International Knee Documentation Committee (IKDC) Subjective

Secondary study objectives

Prone Hamstring Strength at 6 Months

Return to Sport (RSI) Patient Reported Outcomes Score at 6 Months.

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Bridge-Enhanced ACL Repair (BEAR)Experimental Treatment1 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 GraftActive Control1 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.

0 / 10Eligibility criteria met