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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
Sex: Both male and female
Age: 14 to 35 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years after surgery
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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My gender does not affect my eligibility.
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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.
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My surgery is scheduled within 45 days of my injury.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Instrumented Anteroposterior (AP) Laxity Testing
International Knee Documentation Committee (IKDC) Subjective
Secondary outcome measures
Prone Hamstring Strength at 6 Months
Return to Sport (RSI) Patient Reported Outcomes Score at 6 Months.

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.

Find a Location

Who is running the clinical trial?

Miach OrthopaedicsLead Sponsor
4 Previous Clinical Trials
1,220 Total Patients Enrolled
2 Trials studying Anterior Cruciate Ligament Tear
220 Patients Enrolled for Anterior Cruciate Ligament Tear
Dennis Krammer, MDPrincipal InvestigatorBoston Children's Hospital

Media Library

BEAR Scaffold (Device) Clinical Trial Eligibility Overview. Trial Name: NCT02664545 — N/A
Anterior Cruciate Ligament Tear Research Study Groups: Bridge-Enhanced ACL Repair (BEAR), Tendon Graft
Anterior Cruciate Ligament Tear Clinical Trial 2023: BEAR Scaffold Highlights & Side Effects. Trial Name: NCT02664545 — N/A
BEAR Scaffold (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02664545 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this research project still open?

"The clinicaltrials.gov information dictates that as of the September 10th 2021 update, this trial is not actively recruiting participants. However, there are 100 other studies with open enrollment at present."

Answered by AI

Can I be accepted into this investigation?

"This medical study is welcoming a total of 100 test subjects, aged 14 to 35 years old, who have suffered an anterior cruciate ligament tear. In addition to the age requirement, it must be noted that individuals participating must identify as male or female; possess a fully-torn ACL; and have had their MRI taken 45 days at most following injury. Importantly, there must still be evidence of ACL tissue on preoperative MRI imaging - with more than half of its length attached to the tibial plateau."

Answered by AI

Does this experiment admit minors as participants?

"The prerequisites for this clinical trial are that participants are between the ages of 14 and 35. Those younger than 14 can join 47 other trials, while those older than 65 have 25 options available to them."

Answered by AI
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~11 spots leftby Mar 2025