Quantifications of Biochemical Changes of Synovial Fluid and Cartilage Matrix in Osteoarthritic Knee After Hyaluronic Acid Injection Using Novel MRI (Magnetic Resonance Imaging) and NMR (Nuclear Magnetic Resonance) Techniques
Overview
- Phase
- Phase 4
- Intervention
- Euflexxa
- Conditions
- Knee Osteoarthritis
- Sponsor
- University of California, San Francisco
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- To Identify Imaging Markers for Characterizing the Biochemical Profiles in Synovial Fluid and Cartilage in Knee OA After HA Injection
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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:
- High-field HRMAS NMR spectroscopy will provide sensitive measures for biochemical changes within knee synovial fluid after HA injection;
- 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;
- 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.
Investigators
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
Arms & Interventions
Euflexxa
EUFLEXXA® is a hyaluronate hydrogel produced from bacteria, in a phosphate-buffered saline solution. It is given as a three week treatment regimen. It involves injecting of 2cc or 20mg intra-articularly once per week.
Intervention: Euflexxa
Euflexxa
EUFLEXXA® is a hyaluronate hydrogel produced from bacteria, in a phosphate-buffered saline solution. It is given as a three week treatment regimen. It involves injecting of 2cc or 20mg intra-articularly once per week.
Intervention: Magnetic Resonance Imaging (MRI)
Outcomes
Primary Outcomes
To Identify Imaging Markers for Characterizing the Biochemical Profiles in Synovial Fluid and Cartilage in Knee OA After HA Injection
Time Frame: 3 months
The study will demonstrate the feasibility of using MRI and NMR techniques to quantify biochemical changes in synovial fluid and cartilage matrix in OA knees after HA injection.
Secondary Outcomes
- To Quantify Synovial Fluid Biochemical Changes Using High Field HRMAS NMR Spectroscopy(3 months)