To Look at the Characteristics of Synovial Fluid and Cartilage Matrix in Osteoarthritic Knee After Hyaluronic Acid Injection
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Euflexxa; Magnetic Resonance Imaging (MRI)
Intervention description: Euflexxa will be injected weekly for 3 consecutive weeks on the knee joint.; MRI of the knee will be acquired during baseline (a week prior to the treatment), follow up visit 1 (1 week after treatment) and follow up visit 2 (3 months after treatment).
Intervention MeSH terms: Hyaluronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: knee osteoarthritis (OA); hyaluronic acid injection

Summary:

      The purpose of this study is to identify novel imaging markers for characterizing the
      biochemical profiles in synovial fluid and cartilage matrix in OA knee joints after
      intra-articular HA (Euflexxa) injection using high field NMR and MRI techniques.

      We hypothesize that:

        1. High-field HRMAS NMR spectroscopy will provide sensitive measures for biochemical
           changes within knee synovial fluid after HA injection;

        2. Baseline HRMAS spectroscopy, in particular N-acetyl peaks, as well as early changes of
           glutamate will predict patient response of pain relief after HA injection;

        3. MR cartilage T1p and T2 quantifications will provide sensitive measures for biochemical
           changes within knee cartilage matrix after HA injection. Specifically cartilage T1p and
           T2 will decrease in patients who respond to the treatment, indicating potential
           beneficial effects of HA injection to cartilage preservation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 to 80 years

          -  Symptomatic knee OA as defined by the American College of Rheumatology criteria

          -  Kellgren-Lawrence grade I, II or III on prior x-rays (take within 6 months of
             screening visit)

          -  knee pain score >40 mm on a 100 mm visual analogue scale for > 15 days in the last
             month

          -  NSAIDs permitted if the dose has been stable for at least one month prior to baseline
             and stays stable during the study

          -  Have been recommended for Euflexxa treatment by physician

          -  Knee effusion based on clinical exam or imaging

        Exclusion Criteria:

          -  Any contraindication to MRI (pregnancy, metallic fragments in the eyes, vascular
             clips, Pacemakers etc)

          -  History of knee replacement

          -  Known sensitivity or allergy to any component of Euflexxa

          -  Inflammatory arthritis

          -  Previously received viscosupplementation therapy within 6 months of study enrollment

          -  Intra-articular injection of corticosteroid to study joint within the past 3 months

          -  Arthroscopic or open surgery within the previous 12 months or planned surgery to the
             study joint

          -  Concomitant medications of oral/parenteral corticosteroids

          -  Morbid obesity defined as body mass index (BMI) >40 kg/m2

          -  Active malignancy; an active systemic infection; recent high impact or high energy
             trauma (clinically defined) to the study joint

          -  Large knee effusion based on clinical exam or imaging