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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Kaohsiung、台湾、813
- Department of Physical Medicine and Rehabilitation, Veterans General Hospital,
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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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研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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visual analog scale
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Lequesne index
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Shu-Fen Sun, MD、Veterans General Hospital, Kaohsiung;National Yang-Ming University School of Medicine, Taiwan
- 主任研究者：Chien-Wei Hsu, MD、Department of Internal Medicine, Kaohsiung Veterans General Hospital
- 主任研究者：Hsien-Pin Sun, MD、Cheng Ching Hospital, Taiwan
- 主任研究者：Hung-Ju Li, MS、Institute of Statistics, National University of Kaohsiung, Taiwan
- 主任研究者：Jue-Long Wang, MD、Kaohsiung Veterans General Hospital, Taiwan
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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Hya-Jointの臨床試験
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Taiwan Bio Therapeutics Inc.A2 Healthcare Taiwan Corporation完了
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Huazhong University of Science and TechnologyBeijing Friendship Hospital; Qilu Hospital of Shandong University; Sir Run Run Shaw Hospital; Shanghai... と他の協力者まだ募集していません
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Jan Biziel University Hospital No 2 in BydgoszczCharles University, Czech Republic; University Hospital Kralovske Vinohrady招待による登録