Bridge-Enhanced ACL Repair-Safety Study (BEAR Trial)

Inflammatory reaction

Tense effusion limiting motion, fever or increased knee pain for more than three weeks after surgery and synovial fluid culture is negative for organisms.

Time frame: Surgery to 3-months post-op

Muscle Atrophy

Patient cannot ambulate independently and continues to require crutches for ambulation for more than six weeks after surgery as a result of the muscle weakness. Patient report leg feels unstable ambulating without crutches at six weeks after surgery.

Time frame: At 6-weeks post-op

Excessive Pain

Patient needs to be readmitted to the hospital for parenteral (IV or IM) pain medications but no other adverse event (e.g. infection or inflammation) is found.

Time frame: Surgery to 3-months post-op

Implant failure

Lachman exam demonstrates 6mm or greater AP knee laxity when the knee is in 25 degrees of flexion in the operated knee than the unoperated knee on examination by the physician in the office. Both knees will be covered and the examining physician blinded to which knee was the surgical knee prior to the testing.

Time frame: At 3-months post-op

Anteroposterior (AP) knee laxity

KT-1000 testing of AP laxity in both knees reveals a side-to-side difference of \>=6mm when performed by the clinician. The knees will be covered and the examiner blinded as to which is the operated knee.