Controlled Study of Kneehab XP for Patients Undergoing Total Knee Replacement

The study is a double-blind randomized controlled clinical trial of approximately 118
patients (males and females) who are at least 40 years of age, who are scheduled for Total
Knee Arthroplasty (TKA) surgery will be randomized into 1) a treatment group who receive
Kneehab XP and a standard rehabilitation program and 2) a control group who receive only a
sham device and a standard rehabilitation program. Patients are tracked for measures of
function, pain, quality of life, physical performance and acceptable states status at 6 weeks
and 1 week before surgery and 3, 6, 12, and 52 weeks following surgery.

Inclusion Criteria:

- Individuals who are scheduled for Total Knee Replacement surgery with the Smith and
Nephew Visionaire prosthesis and the anterior surgical approach.

- Individuals who are at least 40 years of age.

- Individuals with a body mass index (BMI) <40 kg/ m2

- Individuals who are walking independently with or without assistive devices.

- Individuals with a Short Performance Battery Score greater than 7.

- Must be able and willing to complete all study assessments and to be followed for the
full course of the study.

- Must be able to read, write and follow instructions in English.

- Must be able and willing to provide informed consent.

- Must be willing and able to attend the additional pre-operative assessment.

Exclusion Criteria:

- Individuals with a history of foot and/or ankle pathology.

- Individuals with a history of tibial or femoral fractures.

- Individuals with a history of any underlying neurological conditions.

- Individuals with physical conditions which would make them unable to perform study
procedures.

- Individuals with a total hip replacement.

- Individuals undergoing revision TKA of the same operated leg.

- Individuals who are pregnant.

- Individuals diagnosed with a medical condition that would contraindicate treatment
with the product, e.g. skin lesions at electrode site.

- Individuals with an active implanted medical device (i.e. pacemaker, pump)

- Individuals with a history of stroke

- Individuals with a history of neurological disorder that affects lower extremity
function (stroke, peripheral neuropathy, Parkinson's disease, multiple sclerosis,
etc.)

- Individuals with a diagnosis of inflammatory arthritis (Rheumatoid arthritis, gout or
psoriatic arthritis).

- Individuals with muscle diseases (i.e. muscular dystrophy)

- Individuals with visible skin injury or disease on their legs.

- Individuals who have been committed to an institution by virtue of an order issued
either by the courts or by an authority.