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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
250
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.
Scripps Health
San Diego, California, United States
Florida Orthopedic Institute
Tampa, Florida, United States
Emory University School Of Medicine
Atlanta, Georgia, United States
Ochsner Sports Medicine Institute
New Orleans, Louisiana, United States
MedStar Health Surgery Center of Timonium
Lutherville, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Virtua Health
Marlton, New Jersey, United States
Cynthia Chrostek
Providence, Rhode Island, United States
Orthopedic Institute of Sioux Falls
Sioux Falls, South Dakota, United States
UT Southwestern
Dallas, Texas, United States
...and 1 more locations
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 frame: 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 frame: Time points up to two years.
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 frame: Time points up to two years
Repair Failure
The number of times patients develop recurrent knee stability and require another ACL surgery.
Time frame: Two years
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