Effectiveness of a Knee Brace When Combined With Viscosupplementation in the Treatment of Knee Osteoarthritis

A randomized prospective study to assess the effectiveness of treating knee osteoarthritis
with either a series of three viscosupplementation injections, an off-loading knee brace, or
a combination of viscosupplementation and an off-loading knee brace. The
viscosupplementation and off-loading knee brace are being used in accordance with their FDA
approval. Subjects will be randomized to 1 of 3 treatment groups. The control group will
receive a series of weekly (3 consecutive weeks) intra-articular hyaluronic acid injections.
The second group will receive a series of weekly (3 consecutive weeks) intra-articular
hyaluronic acid injections and an off loading knee brace. The third group will use the off
loading knee brace alone. Subjects will complete the WOMAC Osteoarthritis Questionnaire
(pain, stiffness, function) and VAS pain scale (measuring pain on movement) at baseline, day
7, day 14, 6 weeks and 3 months. Subjects in group 2 and 3 will be given a brace diary to
record compliance.

Inclusion criteria:

- Subjects, over the age of 18, with a diagnosis of knee osteoarthritis which is
confirmed by radiographs.

- Radiographs will be obtained and patients with mild to moderate knee osteoarthritis
will qualify a subject for enrollment.

- Subjects will also have a documented varus deformity.

Exclusion criteria:

- Subjects with severe arthritis as demonstrated by radiographs.

- In addition those subjects with a known or suspected joint infection and subjects who
had undergone arthrocentesis and/or intra-articular injection within 3 months of the
study will be excluded.

- Female patients who are pregnant or breast feeding will also be excluded.