Safety and Effectiveness of HYAJOINT Plus Synovial Fluid Supplement for the Treatment of Knee Osteoarthritis Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 主要终点
- The reported adverse events
研究概览
简要总结
The aim of this study was to compare single injection HYAJOINT Plus Synovial Fluid Supplement used on the single and repeat treatment of knee osteoarthritis that has the same safety and effectiveness as three-injection hyaluronan, Hyalgan.
详细描述
The study was a random, evaluator-blinded, controlled, single center clinical trial. Recruiting patients who have been suffered from the osteoarthritis pain under conventional nonpharmacologic therapy or analgesics for a long time and randomly divided into two groups, HYAJOINT Plus or Hyalgan group, when the inclusion criteria was met and the inform consent was obtained. They were followed for 56 weeks including visits at 4, 12, 26, 39, and 52 weeks post-treatment for the safety and effectiveness evaluation. After complete 52-week visit, subjects would received HYAJOINT Plus on the target knee. These subjects were followed for 4 weeks to assess the safety of repeat treatment or cross reactions of the use from three-injections to single-injection hyaluronan treatment. The primary endpoints were the incidence of any adverse events during the study, as well as the objective assessment of pain visual analog scale at baseline and every visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic knee osteoarthritis for at least 6 months despite nonoperative treatment and/or physical therapy
- •Average knee pain score ≧ 30 mm on a 100-mm VAS
- •Kellgren-Lawrence grade 2 or 3 knee osteoarthritis based on radiographs taken within previous 6 months 18
- •If the VAS pain score of the contralateral knee with radiographic evidence of bilateral knee osteoarthritis was < 30 mm
排除标准
- •Kellgren-Lawrence grade 4 on target knee
- •Clinical apparent active symptoms like infections
- •Intra-articular injections of hyaluronan within the past 6 months
- •Previous orthopaedic surgery on spine or lower limb
- •Intra-articular injections of steroid type drugs within the past 3 months
- •Diagnosed as Lupus erythematosus, Rheumatoid arthritis, Hemiparesis, Neoplasm or received hemodialysis
- •Known allergy to avian proteins or hyaluronic acid products
- •Women ascertained or suspected pregnancy or lactating
研究组 & 干预措施
HYAJOINT Plus group
The HYAJOINT Plus group received one intraarticular injection of 3 ml HYAJOINT Plus and be followed for 52 weeks. A single injection of HYAJOINT Plus was performed if criteria was met at 52 weeks, and a 4-weeks follow-up of adverse events was conducted.
干预措施: HYAJOINT Plus (Device)
Hyalgan group
The Hyalgan group received intraarticular injection of 2 ml Hyalgan for three continuously weeks and be followed for 52 weeks. A single injection of HYAJOINT Plus was performed if criteria was met at 52 weeks, and a 4-weeks follow-up of adverse events was conducted.
干预措施: Hyalgan (Device)
结局指标
主要结局
The reported adverse events
时间窗: 1, 3, 6, 9 and 12 months post-injection
Any adverse events reported by the patients during the study period and physical examination findings by the evaluator after injections and at each follow-up visit.
VAS pain score
时间窗: Baseline, 1, 3, 6, 9 and 12 months post-injection
The change from baseline in a Visual analog scale score for pain. The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'.
次要结局
- WOMAC, Likert Scale(Baseline, 1, 3, 6, 9 and 12 months post-injection)
- VAS satisfaction score(1, 3, 6, 9 and 12 months post-injection)
- VAS stiffness score(Baseline, 1, 3, 6, 9 and 12 months post-injection)
- Timed Up-and-Go test (TUG)(Baseline, 1, 3, 6, 9 and 12 months post-injection)