The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration

A Prospective Cohort Clinical Trial Evaluating Age as a Risk Factor for Poor Outcomes of Bridge-Enhanced ACL Restoration (BEAR)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Injury
• Intervention / Treatment: Device: Bridge-Enhanced ACL Restoration (BEAR)

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.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rita A Paparazzo, BS/MBA; Phone Number: 107 +18005906995; Email: clinicaltrials@miachortho.com
• Study Contact Backup: Name: Kim Mooney, BS; Phone Number: +18005906995; Email: clinicaltrials@miachortho.com

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • Scripps Health
  • Florida
    • Tampa, Florida, United States, 33637
      • Florida Orthopedic Institute
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory University School of Medicine
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Sports Medicine Institute
  • Maryland
    • Lutherville, Maryland, United States, 21093
      • MedStar Health Surgery Center of Timonium
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Virtua Health
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Cynthia Chrostek
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Orthopedic Institute of Sioux Falls
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Inova Sports Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 78 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

-

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.

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bridge-Enhanced ACL Restoration (BEAR); 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	Device: Bridge-Enhanced ACL Restoration (BEAR); In the BEAR Procedure, surgery is performed to sew the ACL back together and a scaffold is placed between the torn ends at the time of repair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Knee Documentation Committee Subjective Score (IKDC) (Survey)	This is a survey patients complete about how their knee is feeling and functioning. Range is 0 to 100, with 100 indicating no problems and 0 indicating extreme problems.	Time points up to two years
International Knee Documentation Committee Objective Score (IKDC) (Physical Exam)	This is an examination performed of the knee. Scores are one of four measures: A (Normal), B (Nearly Normal), C (Abnormal) and D (Severely Abnormal). A is the best outcome and D is the worst.	Time points up to two years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Injury and Osteoarthritis Score (KOOS) questionnaire	This is a survey with 5 subscales (Pain, Symptoms, Function in Daily Living, Function in Sport and Recreation, and Knee Related Quality of Life). The range of each subscale is 0 to 100, with 100 indicating no problems and 0 indicating extreme problems. The subscales are reported individually and not combined.	Time points up to two years
Repair Failure	The number of times patients develop recurrent knee stability and require another ACL surgery.	Two years

Collaborators and Investigators

• Sponsor: Miach Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2018
• Primary Completion (Estimated): April 17, 2024
• Study Completion (Estimated): April 17, 2034

Study Registration Dates

• First Submitted: November 17, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (Actual): November 21, 2017

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Rupture; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: BEAR III Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes