Effect of Steroid Injections in a Knee With Osteoarthritis
Condition: Osteoarthritis (OA) of the Knee
MeSH terms: Osteoarthritis
Intervention: Triamcinolone Acetonide; 0.9% Sodium Chloride Injection as Placebo
Intervention description: 40 mg into the study knee joint every 12 weeks for a total of 8 injections.; Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 140.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No
Keywords: OA; Knee arthritis; MRI; Steroid

Summary:

      A steroid (triamcinolone) 40 mg will be compared to placebo in a randomized
      placebo-controlled clinical trial testing the effect of this steroid versus placebo given
      into the study knee joint that has osteoarthritis (OA). The knee injection will be given once
      every 12 weeks over two years for a total of eight knee injections. How well each participant
      tolerates each injection and all the injections over time will be assessed. The safety of
      getting a knee injection every 12 weeks will be assessed by collecting reported adverse
      effects, knee examinations, and clinical laboratory tests. Participants will complete
      questionnaires, X-ray, MRIs, and bone density tests as part of this study.
    

Eligibility criteria:

        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