ACL-reconstruction vs ACL-reconstruction With EAT

Screening Protocol All participants that express interest in the study will receive a
screening interview that will determine eligibility for participation in the study. The
screening of surgical patients will be performed by one of the clinical research coordinators
in the clinic of Dr. Musahl.

Potential participants who pass the screening interview will be provided a copy of the
informed consent form (in person or via email). The potential participant will review the
consent form in detail with a member of the clinical team in order to ensure that the
participant understands the information contained in the consent form and to provide an
opportunity for the participant to ask questions about the study. If the potential
participant then agrees to participate, the consent form will be signed by the participant
and a member of the clinical team.

Surgical Protocol Baseline testing before surgery will consist of the IKDC objective and
subjective score, KOOS score, Marx activity level, Lysohm Scale and VR-12. A radiologist will
grade clinical MRI for ACL, meniscus, MCL, LCL, and ALC injury. Quantitative pivot shift
testing will be performed under anesthesia using the PIVOT technology and inertial sensor.
Intraoperative grading of ACL injury and concomitant injuries to the articular cartilage and
meniscus will be performed. If deemed eligible final randomization will occur following
intraoperative grading.

Standard single bundle anatomic ACL reconstruction will be performed for all subjects.
Quadrupled hamstring tendon will be used with cortical fixation on femur and tibia. ACL-R+EAT
will be performed as described by Marcacci with doubled hamstring tendon left attached at the
pes anserinus, an anatomic tibial tunnel, staple fixation in the over the top position,
routing of the graft superficial to the LCL, and staple fixation at Gerdy's tubercle.
Concomitant tears to the menisci and their roots will be repaired as indicated.

Research Scans After surgery, approximately 6 months, subjects will undergo a CT scan on
bilateral knees. The CT scan will be used to create volumetric models. These bone models will
be matched to the dynamic biplane x-rays. Subjects will also undergo a research MRI scan on
bilateral knees. The MRI scan will be used to generate models of the knee articular
cartilage.

Testing Protocol Participants who pass the screening interview, consent to participate in
this study and undergo surgical treatment will be scheduled for two test sessions at the
University of Pittsburgh Biodynamics Lab, a research CT scan and MRI scan at UPMC
Presbyterian. The participant will then be assigned a study ID number that will be used to
identify all de-identified data associated with the participant. The study ID number will be
recorded and placed with the consent form in a folder that will remain in a locked file
cabinet in the Biodynamics Lab.

Female participants will complete a urine pregnancy test at the Biodynamics Lab prior to
X-ray, CT or MRI scans. The results of the pregnancy test will be documented by either the PI
or Research Assistant and retained in a separate folder that is identified only by the
participant's Study ID number.

Functional biomechanical outcomes will be measured at 6 months and 12 months using DSX at the
Biodynamics Lab. Data will be obtained from the bilateral knees while the subjects perform a
downhill running and a cutting maneuver task to simulate pivoting, each task will be repeated
three times to ensure capture of movement. There will be at most 3 static standing trials
before each movement tasks to image each knee. Participants will be tested within a biplane
X-ray system throughout the study. Biplane radiographic images of each knee will be taken for
20 surgical patients, randomly assigned to ACL-R or ACL-R+EAT .

In the patient prep-room of the Biodynamics Lab, a member of the research team will place
reflective markers throughout the body. Movement of the reflective markers will be tracked
using conventional optical motion tracking equipment (Vicon MX).

Novel's pedar system will be used to measure pressure distribution under the foot for each
participant during the dynamic movement trials. Each participant will be fitted with an
elastic sensor insole (1.9 mm thickness) which will be connected to a data logging pack via
cables. The cables will be secured around the participant's legs with velcro to minimize
potential interference during the movement trials. The data logging pack will be fitted on a
belt that will sit around the participants hip. The data logging pack will send data to the
computer system via Bluetooth.

All trials will be performed on an instrumented treadmill that will collect ground reaction
forces at 1000 Hz during each movement trial. This system contains two side-by side 30x180 cm
belts. The belts are driven by independent (but synchronized) motor systems, and each
belt/motor is configured on a rigid platform supported by multi-axis load cells. This
configuration enables assessment of three-dimensional foot-ground reaction forces (vertical/
medial/lateral and anterior/posterior), applied torque and center-of-pressure location
independently for each foot. The participants will perform some activities for the ankle on
risers placed on the treadmill belt in order to image the ankle with the DSX machines. The
treadmill belt will not move for the ankle trials, it will just be used to determine ground
reaction forces.

The demographic questionnaire will then be completed and the PI, Research Assistant or Lab
Manager will place the questionnaire into the folder containing de-identified participant
information. This will include age, sex, height, weight and body mass index (BMI) along with
standard anthropometric measurements used by our Vicon Nexus motion measurement system.
Participants will aslo fill out the following questionnaires: IKDC subjective, KOOS, SAS97,
VAS, Marx activity level, Lysohm Scale and VR-12.

INCLUSION CRITERIA:

1. between age of 14-40

2. BMI between 18-35

3. have a contralateral healthy knee and within 12 months of grade 3 injury to the
ipsilateral ACL

4. no greater than grade 2 injury to MCL or LCL and absence of PCL injury

5. articular cartilage injury grade 2 or lower

6. display a quantitative pivot shift test of >=3 mm lateral translation or >8 m/sec*2,
or a side to side difference of 50% or greater

7. Use of a quad tendon graft or BTB graft

EXCLUSION CRITERIA:

- Subjects will have no other injury or disease that will interfere with knee function.
Subjects will be of generally good health and will have decided to undergo ACL
reconstruction surgery and agreed to participate in the study (following informed
consent procedures).

- Potential candidates who do not intend to stay in the Pittsburgh area for a period of
at least a year following surgery will be excluded.

- Pregnant females will be excluded. Urine pregnancy tests will be administered by the
PI prior to research-related exposure to radiation (CT scan, Biodynamics Lab testing).
If these radiation exposures occur on the same date, only one pregnancy test will be
administered. If these radiation exposures occur on different dates, a pregnancy test
will be administered each date.