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Summary

Bridge-Enhanced ACL Restoration (BEAR) is a new procedure being developed to treat patients with ACL injuries. In the BEAR procedure, an implant is placed between the torn ends of the ACL and the patient's own blood is added to the implant to stimulate ligament healing. We propose the current study to determine if older patients do better than younger patients (or vice versa) with this procedure. This is a cohort study designed to determine if age is a risk factor for a worse outcome after a bridge-enhanced ACL repair (BEAR) as defined by an 11.5 point difference on the IKDC Subjective or Objective Knee Evaluation score at two years after surgery. Additional objectives are to determine the effect of age on safety outcomes including infection, graft rejection, and need for further surgical procedures.

Conditions

Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Rupture

Recruitment Status

Recruiting

Detailed Description

The BEAR III study is a cohort study designed to determine if age is a risk factor for a worse outcome after a bridge-enhanced ACL restoration (BEAR) as defined by an 11.5 point difference on the IKDC Subjective or Objective Knee Evaluation score at two years after surgery. Additional objectives are to determine the effect of age on safety outcomes including infection, graft rejection, and need for further surgical procedures.

Eligibility Criteria

Inclusion Criteria: ACL tear, within 50 days of injury, at least 5% of the ACL attached to the tibia.

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Exclusion Criteria: Prior surgery on the affected knee, history of knee infection, use of tobacco, use of corticosteroid, chemotherapy, allergy to bovine products or gelatin, history of anaphylaxis, BMI over 35, moderate osteoarthritis.

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Intervention

Intervention Type

Intervention Name

Device

Bridge-Enhanced ACL Restoration (BEAR)

Phase

Not Applicable

Gender

All

Min Age

12 Years

Max Age

80 Years

Download Date

May 25, 2022

Principal Investigator

N/A

Primary Contact Information

Rita A Paparazzo, BS/MBA

+18005906995

clinicaltrials@miachortho.com

Kim Mooney, BS

+18005906995

clinicaltrials@miachortho.com

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: