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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- To Identify Imaging Markers for Characterizing the Biochemical Profiles in Synovial Fluid and Cartilage in Knee OA After HA Injection
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Euflexxa (Drug)
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.
干预措施: Magnetic Resonance Imaging (MRI) (Device)
结局指标
主要结局
To Identify Imaging Markers for Characterizing the Biochemical Profiles in Synovial Fluid and Cartilage in Knee OA After HA Injection
时间窗: 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.
次要结局
- To Quantify Synovial Fluid Biochemical Changes Using High Field HRMAS NMR Spectroscopy(3 months)