A Prospective Pilot Study to Evaluate Efficacy and Safety of Euflexxa for the Treatment of Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Hyaluronate Concentration
研究概览
简要总结
The effect of Euflexxa therapy for knee osteoarthritis on levels of inflammatory and degenerative synovial fluid bio-markers in patients with knee osteoarthritis
详细描述
The FLEXX trial was the first well-controlled, randomized, double-blind, multicenter study evaluating the efficacy of Euflexxa (1% sodium hyaluronate) therapy for knee osteoarthritis. Five-hundred-and-eighty patients were randomized to receive either Euflexxa or normal saline. There were significant improvements in the Visual analogue scale score Osteoarthritis Research Society International responder index, HRQoL, and function at 26-week follow-up.1 However, the FLEXX trial did not evaluate changes in synovial fluid bio-marker levels. The present study will be a prospective pilot study of 30 knees from subjects who receive intra-articular Euflexxa. The primary objective of this study is to prospectively determine, at 6-weeks, and 6-months post treatment, the changes in levels of synovial fluid biomarkers from pre- to post-injection in patients who receive Euflexxa. In addition, we will assess patient reported pain and patient reported outcomes up to 2 years from initiation of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OA of the knee by American College of Rheumatology criteria
- •Those who failed non-pharmacological measures or simple analgesics
- •moderate to severe pain score of 41 to 90 mm recorded on 100-mm visual analog scale (VAS) immediately following a 50-foot walk
- •bilateral standing anterior-posterior radiograph demonstrating Kellgren and Lawrence grade 2 or 3 OA of the target knee
- •ability and willingness to use only acetaminophen as the analgesic (rescue) study medication
- •unassisted walking 50 feet on a flat surface and going up and down stairs
- •willingness and ability to complete efficacy and safety questionnaires
排除标准
- •Age less than 18 years
- •any major injury to the target knee within the prior 12 months
- •any surgery to the target knee within the prior 12 months
- •surgery to the contralateral knee or other weight-bearing
- •inflammatory arthropathies
- •gout or pseudogout within the previous 6 months
- •radiographic acute fracture, severe loss of bone density, avascular necrosis, and/or severe bone or joint deformity in the target knee
- •osteonecrosis of either knee
- •fibromyalgia, pes anserine bursitis, lumbar radiculopathy, and/or neurogenic or vascular claudication
- •target knee joint infection or skin disorder/ infection within the previous 6 months
- •symptomatic OA of the hips, spine, or ankle; known hypersensitivity to acetaminophen, IA-BioHA, or phosphate-buffered saline solution
- •Women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the study
- •history of immune disorders; vascular insufficiency of lower limbs or peripheral neuropathy
- •current treatment or treatment of cancer within the previous 2 years (excluding basal cell or squamous cell carcinoma of the skin)
- •active liver or renal disease
- •any clinically significant abnormal laboratory value [to be defined in detail at a later point]
- •any intercurrent chronic disease or condition that might interfere with the completion of the study
- •participation in any experimental device study within the prior 6 months or any experimental drug study within the prior month
研究组 & 干预措施
Euflexxa
Two sets of Euflexxa injection at 0 and 6 months. Each set consists of 3 injections 1 week apart.
干预措施: Euflexxa (Device)
结局指标
主要结局
Change in Hyaluronate Concentration
时间窗: Baseline to 6 months
The concentration of hyaluronate in the synovial fluid will be measured using Fluorophore-assisted carbohydrate electrophoresis. The difference between the mean concentration at baseline and 6 months is reported.
次要结局
- VAS Pain Score Improvement(Baseline to 6 months)
- Changes in Tumor Necrosis Factor-stimulated Gene 6 (TSG-6)(Baseline to 6 months)
研究者
Carlos Higuera-Rueda
Vice Chair for Quality and Patient Safety
The Cleveland Clinic