Efficacy of Three Weekly Injections of a Bacterial-- Sourced Hyaluronate on Pain and Function in Patients With Knee Osteoarthritis (OA)
Efficacy of 3 Weekly Injections of a Bacterial-- Sourced Hyaluronate on Pain and Physical Function in Patients With Knee Osteoarthritis-a Randomized Controlled Clinical Trial
研究概览
详细说明
Background: Viscosupplementation with intra-articular hyaluronate injections is a safe and effective treatment of knee osteoarthritis. There are several forms of hyaluronate with different origin, method of production, molecular weight, dosing instructions and possibly clinical outcomes. Most current hyaluronate products are avian in origin, and only few are bioengineered via bacterial fermentation. The purpose of this study was to evaluate the efficacy and safety of 3 weekly injections of a bacterial-sourced hyaluronate (Hya-Joint) in patients with knee osteoarthritis.
Methods: As a prospective randomized observer-blind study done in a university-affiliated tertiary care medical center, patients with knee osteoarthritis for at least 6 months were enrolled. Eligible patients were randomized to receive three weekly intraarticular injections of either bacterial-sourced hyaluronate (Hya-Joint) or avian-derived hyaluronate (Hyalgan) into the target knee. The primary outcome was the visual analog scale (VAS) change from baseline for knee pain at 6-month follow-up. Secondary outcome measures included Lequesne index, timed up and go test (TUG), patients' global satisfaction and analgesics consumption.
Results: A total of 95 participants were randomly assigned and 89 participants completed the study. Both groups had significant improvements in pain as early as 1 and 2 weeks after the first injection, and the pain-reduction effects could last for 6 months, with no between-group differences. The Lequesne index scores and results of TUG tests improved significantly from baseline in both group at all follow-up visits (p<0.001 for each test compared with baseline), with no significant between-group differences at 1-month and 6-month follow-up. However, significantly greater improvements favoring the Hya-Joint group were noted at 3-month follow-up (p<0.05). No between-group differences were seen regarding the use of analgesics. Both groups reported high satisfaction at 6-month follow-up. No serious adverse events occurred.
Conclusions: Three weekly injections of hyaluronate (Hya-Joint) are safe and well tolerated, provide rapid pain relief as early as 1 and 2 weeks after the first injection, and improve function in patients with knee osteoarthritis. The treatment effects can last for 6 months.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Kaohsiung、台湾、813
- Department of Physical Medicine and Rehabilitation, Veterans General Hospital,
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- (1) age 40 years or older, presence of a primary knee OA with knee pain for at least 6 months despite conservative treatment (rest, physical therapy, orthoses or pain medications etc.); (2) had average pain on knee movement of at least 3 cm on a 10-cm VAS; (3) had a current Lequesne index score (described below) >7 (possible range, 0-24); (4) were willing to discontinue all nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesic medication (except for rescue medication) for the duration of the study; and (5) were willing to not receive physical therapy or trial of shoe modifications or orthoses during the study period.
Exclusion Criteria:Exclusion criteria included previous orthopedic surgery on the spine or lower limbs, knee instability or marked deformity on examination, clinically apparent tense effusion of the knee, intra-articular steroid or HA injection in any joint within the past 6 months, and concomitant inflammatory arthropathy or other rheumatologic, neurological, cardiovascular or psychiatric disorders that would interfere with the clinical assessment during the study period.
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学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Hya-Joint
The Hya-Joint group received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hya-Joint, derived from Streptococcus zooepidemicus and produced by a highly purified biologic fermentation process, molecular weight 650-1200 kDa),into the target knee.
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The Hya-Joint group received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hya-Joint, derived from Streptococcus zooepidemicus and produced by a highly purified biologic fermentation process, molecular weight 650-1200 kDa),into the target knee.
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有源比较器：Hyalgan
the control group received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (, extracted from chicken combs, molecular weight 500-730kDa) into the knee joints.
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The control group received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan, extracted from chicken combs, molecular weight 500-730kDa) into the knee joints.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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visual analog scale
大体时间：6 months after the third injection
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The patient rated the intensity of pain with regard to average pain on knee movement over the previous week using a 10-cm horizontal VAS (10-cm line; 0= no pain to 10= worst imaginable pain)
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6 months after the third injection
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Lequesne index
大体时间：6 months after the third injection
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Lequesne index was used to assess severity of knee symptoms during the last week23.
It is validated and includes the measurement of pain (5 items), walking distance (2 items), and activities of daily living (4 items).
Maximal score is 24 and higher scores represent worse function
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6 months after the third injection
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Timed " Up-and-Go" test
大体时间：6 months after the third injection.
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Timed " Up-and-Go" test (TUG) is a simple test of basic physical functional mobility for frail elderly persons with high interrater reliability and content reliability24.
A patient is asked to rise from an armchair, walk 3 meters at a safe and comfortable pace, turn around, walk back to the chair, and sit down again.
The whole procedure is demonstrated first before the actual test.
The score is the time in seconds it takes to complete these tasks
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6 months after the third injection.
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the level of global satisfaction
大体时间：6 months after the third injection.
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Patients were asked to rate the level of global satisfaction compared to their preinjection condition at each follow-up visit.
The rating was based on a 7-point categorical scale weighted from completely satisfied, satisfied, somewhat satisfied, no change, somewhat dissatisfied, dissatisfied to completely dissatisfied.
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6 months after the third injection.
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合作者和调查者
调查人员
- 首席研究员：Shu-Fen Sun, MD、Veterans General Hospital, Kaohsiung;National Yang-Ming University School of Medicine, Taiwan
- 首席研究员：Chien-Wei Hsu, MD、Department of Internal Medicine, Kaohsiung Veterans General Hospital
- 首席研究员：Hsien-Pin Sun, MD、Cheng Ching Hospital, Taiwan
- 首席研究员：Hung-Ju Li, MS、Institute of Statistics, National University of Kaohsiung, Taiwan
- 首席研究员：Jue-Long Wang, MD、Kaohsiung Veterans General Hospital, Taiwan
出版物和有用的链接
一般刊物
- Sun SF, Hsu CW, Hwang CW, Hsu PT, Wang JL, Tsai SL, Chou YJ, Hsu YW, Huang CM, Wang YL. Hyaluronate improves pain, physical function and balance in the geriatric osteoarthritic knee: a 6-month follow-up study using clinical tests. Osteoarthritis Cartilage. 2006 Jul;14(7):696-701. doi: 10.1016/j.joca.2006.01.010. Epub 2006 Mar 6.
- Adams ME, Atkinson MH, Lussier AJ, Schulz JI, Siminovitch KA, Wade JP, Zummer M. The role of viscosupplementation with hylan G-F 20 (Synvisc) in the treatment of osteoarthritis of the knee: a Canadian multicenter trial comparing hylan G-F 20 alone, hylan G-F 20 with non-steroidal anti-inflammatory drugs (NSAIDs) and NSAIDs alone. Osteoarthritis Cartilage. 1995 Dec;3(4):213-25. doi: 10.1016/s1063-4584(05)80013-5.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Hya-Joint的临床试验
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Taiwan Bio Therapeutics Inc.A2 Healthcare Taiwan Corporation完全的