Study to Evaluate ACB Versus FNB Early Postoperative Period Functional Outcomes After TKA

Title: Prospective, Double-blind, Randomized Study to Evaluate a Single Shot Adductor Canal
Nerve Block versus Femoral Nerve Block combined with LIA (Local Infiltration Analgesia):
Early Postoperative Period Functional Outcomes after Total Knee Arthroplasty.

Objectives:

Primary: To determine if patients undergoing a Total Knee Arthroplasty who receive an
Adductor Canal block will result in increased quadriceps muscle strength (MVIC) compared to
those who receive a Femoral Nerve block at 24 hours.

Secondary: The secondary objective is to determine whether Adductor Canal nerve block
results in improved functional outcomes as evidenced by Time up and GO, Range of Motion and
Six-Minute Walk Test at 24 hours, 48 hours and 6 months.

To assess post-operative pain as measured by the Visual Analog pain score (VAS) immediately
prior to the start of, during, and after each in-patient physical therapy session.

Study Design: Prospective, double-blind, randomized study

Description of Intervention: The devices to be used in this study are intended for nerve
blocks and consist of 13-6 MHz linear ultrasound transducer (SonoSite HFL38x; Washington,
US), a 22-gauge, 50-mm, short-bevel stimulating needle (Stimuplex; B Braun, Bethlehem,
Pennsylvania), B/Braun Stimuplex DIG RC, Bupivacaine HCl 100 mg injected in the Adductor
Canal or around the Femoral nerve.

Femoral nerve block in combination with local infiltration analgesia is the standard of care
in the investigators institution at present.

Bupivacaine HCl 100 mg in combination with Toradol 30 mg are used for local infiltration of
the anterior lateral and lateral posterior side of the knee, done by the surgeon using a
standard technique.

Subject Population:The study will include both male and female adults who will meet the
inclusion criteria and none of exclusion criteria. For each patient time to conduct the
blocks will vary between 5-10 minutes, local infiltration analgesia between 5-10 minutes,
physical therapy tests between 30 minutes and one hour each encounter, VAS pain assessment
between 2-5 minutes

Subject Participation Duration:The rate of patient accrual, and the prescribed follow-up
time, the total duration of this study is expected to be approximately 18 months where
enrollment is expected to occur over 12 months with a follow-up period of 6 months in the
physical therapy office visits.

Number of Patients:The study will include 120 patients.

Number of Sites: The study will include one site.

Study Duration:The expected study duration is approximately 18 months.

Endpoints: Endpoints of this study will include quadriceps muscle strength, ROM of the knee,
TUG, 6 minute walk test, knee pain score (VAS), activities of daily living, adverse events
and will be studied from the baseline up to 6 month after TKR. VAS pain score will be
assessed at each physical therapy encounter.

Inclusion Criteria:

- Subject is 40-80 years of age and skeletally mature

- Subject BMI is < 40

- Subject has been selected by the surgeon for TKA.

- Subject is taking less than 30 mg of Morphine per day.

- Subject is willing and able to sign a written consent form

- The subject has the mental capacity and the willingness to comply with the specified
follow-up evaluations, and can be contacted by telephone by the site personnel.

- The subject is not pregnant, does not intend to become pregnant and has a significant
other mirroring her intentions.

Exclusion Criteria:

- Subject is not neurologically intact (sensory, motor, and reflex deficit)

- Subject has pain in the limb scheduled for surgery that is out of proportion of
expected pain usual for this pathology

- Subject scheduled for simultaneous bilateral knee replacement

- Subject has a history of any invasive malignancy (except non-melanoma skin cancer),
unless treated with curative intent and with no clinical signs or symptoms of the
malignancy for 5 years

- Subject with prior reconstructive knee surgery on the operated limb

- Subject with primary bone tumor in the knee area

- Subject anticipates having a lower extremity surgery other than the investigational
surgery during the course of the study

- Subject has a history of substance abuse

- Subject is currently involved in another study or have received investigational
product or treatment within the last 30 days

- Subject is pregnant or planning on becoming pregnant during the study period

- Subject is accepting workers' compensation