Clinical trial NCT03348995: The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration
Official title: A Prospective Cohort Clinical Trial Evaluating Age as a Risk Factor for Poor Outcomes of Bridge-Enhanced ACL Restoration (BEAR)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Injury
Anterior Cruciate Ligament Rupture
Lead sponsor: Miach Orthopaedics
Sponsor class: INDUSTRY
First posted: 2017-11-21
Enrollment: 250
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cohort Study
Primary purpose: TREATMENT

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.

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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Primary outcomes:
measure: International Knee Documentation Committee Subjective Score (IKDC) (Survey)
timeFrame: Time points up to two years
measure: International Knee Documentation Committee Objective Score (IKDC) (Physical Exam)
timeFrame: Time points up to two years.
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Score (KOOS) questionnaire
timeFrame: Time points up to two years
measure: Repair Failure
timeFrame: Two years
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Health
state: California
city: Tampa
country: United States
facility: Florida Orthopedic Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University School Of Medicine
state: Georgia
city: New Orleans
country: United States
facility: Ochsner Sports Medicine Institute
state: Louisiana
city: Lutherville
country: United States
facility: MedStar Health Surgery Center of Timonium
state: Maryland
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Marlton
country: United States
facility: Virtua Health
state: New Jersey
city: Providence
country: United States
facility: Cynthia Chrostek
state: Rhode Island
city: Sioux Falls
country: United States
facility: Orthopedic Institute of Sioux Falls
state: South Dakota
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Fairfax
country: United States
facility: Inova Sports Medicine
state: Virginia
Study officials:
References: