Effect of Steroid Injections in a Knee With Osteoarthritis

Inclusion Criteria:

- Female or Male, Age ≥ 45 years

- Chronic knee discomfort based on affirmative response to the question "During the
past 12 months, have you had any pain, aching, or stiffness in or around your knee(s)
on most days for at least one month?"

- Baseline (Month 0) Pain score >2 on at least one of the WOMAC weight-bearing pain
questions; and total weight-bearing pain score <8

- Tibiofemoral or patellofemoral OA on posterior-anterior weight-bearing semi-flexed or
lateral knee radiographs with severity equivalent to Kellgren and Lawrence grade 2 or
3

- Evidence of synovitis on ultrasound at screening

- Clinical examination confirming knee pain or discomfort referable to the knee joint

- Prepared to discontinue NSAID(s)/analgesic(s) for 2 days prior to each assessment

Exclusion Criteria:

- Prior septic (study) knee joint

- Prior reconstructive surgery in the study knee

- Prior osteonecrosis (avascular necrosis of bone)

- Chronic use of oral corticosteroids; knee intra-articular corticosteroid injection
within 3 months of Month 0 (baseline) visit

- Ongoing use of doxycycline, indomethacin, glucosamine and/or chondroitin; or use of
these within 2 months of Screening visit

- Evidence of other inflammatory joint disease (e.g., gout, CPPD)

- Serious medical conditions or impairments that, in the view of the investigator,
would obstruct their participation in the trial such as uncontrolled diabetes,
uncontrolled hypertension, opiate dependency

- Plan to permanently relocate from the region, or take an extended vacation for
greater than 3 months during the trial period

- Planned arthroscopy and/or arthroplasty in the study knee.

- Any contra-indication to having an MRI

- Inability to speak or comprehend English