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

Not Applicable

Active, not recruiting

• Conditions: Anterior Cruciate Ligament Injury; Anterior Cruciate Ligament Rupture
• Interventions: Device: Bridge-Enhanced ACL Restoration (BEAR)

• Registration Number: NCT03348995
• Lead Sponsor: Miach Orthopaedics

Brief 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.

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 Timeline

• Study First Submitted: 2017-11-17
• Study First Submitted QC: 2017-11-17
• Study First Posted: 2017-11-21
• Study Start: 2018-04-17
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Primary Completion: 2025-06-30
• Study Completion: 2034-04-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bridge-Enhanced ACL Restoration (BEAR)	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

Primary Outcome Measures

Name	Time	Method
International Knee Documentation Committee Objective Score (IKDC) (Physical Exam)	Time points up to two years.	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.
International Knee Documentation Committee Subjective Score (IKDC) (Survey)	Time points up to two years	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.

Secondary Outcome Measures

Name	Time	Method
Repair Failure	Two years	The number of times patients develop recurrent knee stability and require another ACL surgery.
Knee Injury and Osteoarthritis Score (KOOS) questionnaire	Time points up to two years	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.

Trial Locations

Locations (11)

MedStar Health Surgery Center of Timonium; 🇺🇸 Lutherville, Maryland, United States

Ochsner Sports Medicine Institute; 🇺🇸 New Orleans, Louisiana, United States

Virtua Health; 🇺🇸 Marlton, New Jersey, United States

Orthopedic Institute of Sioux Falls; 🇺🇸 Sioux Falls, South Dakota, United States

Cynthia Chrostek; 🇺🇸 Providence, Rhode Island, United States

Scripps Health; 🇺🇸 San Diego, California, United States

Florida Orthopedic Institute; 🇺🇸 Tampa, Florida, United States

Emory University School Of Medicine; 🇺🇸 Atlanta, Georgia, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

UT Southwestern; 🇺🇸 Dallas, Texas, United States

Inova Sports Medicine; 🇺🇸 Fairfax, Virginia, United States