変形性膝関節症に対する PL と PRP の有効性の比較：前向き無作為化プラセボ対照試験
変形性膝関節症に対する血小板溶解物と多血小板血漿の有効性の比較：前向き無作為化プラセボ対照試験
This study will focus on grade I to III knee osteoarthritis by randomized controlled trials which comparing the effectiveness between placebo, autologous platelet rich plasma and autologous platelet lysate injections.
調査の概要
詳細な説明
The current methods for treating knee osteoarthritis include delaying the disease progression and joint replacement surgery. The usual treatment methods are mostly temporary, such as taking drug and hyaluronic acid injection. Therefore, finding the safe and effective methods will greatly reduce medical resource, medical expenses and surgery cost, etc., and restore the patient's quality of life. Platelet lysate is the product of complete activation from autologous platelet. It contains rich growth factors and cytokines such as PDGF, TGF-β, VEGF, EGF and IGF, etc. It can support cell growth and doesn't have any white blood cells in it. It is superior to the platelet rich plasma because of reducing the overall inflammatory response and pain of the patient during treatment.
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：WU Chueh-Hung, MD, CIPS
- 電話番号：66473 0223123456
- メール：nojred@gmail.com
研究連絡先のバックアップ
- 名前：Wang Tyng-Guey, MD
- 電話番号：67588 0223123456
- メール：tgw@ntu.edu.tw
研究場所
-
-
-
Taipei、台湾、100
- 募集
- National Taiwan University Hospital
-
コンタクト：
- Wu Chueh-hung, MD,CIPS
- 電話番号：66473 0223123456
- メール：nojred@gmail.com
-
-
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:
- 50 to 80 years old
- Study Subjects must be willing to sign Informed Consent to participate in the study
- In the past month, at least seven consecutive days in the squat, standing, walking or going up and down the stairs, the most serious degree of visual analogy of the knee pain (Visual Analogue Scale) is greater than or equal to 40 (the most pain is 100, not painful is 0)
- Morning joint stiffness is less than 30 minutes
- X-ray：Grade 1-3 radiographic OA as defined by the K-L classification
Exclusion Criteria:
- Knee instability
- The knee joint is obviously deformed (> 5 degree valgus or varus deviation on X-ray)
- Clinical diagnosed as Pes tendinitis, Chondromalacia
- Taking NSAIDs or steroids (including oral and injection) within one week
- Using anticoagulant drugs for a long time
- Platelet count is less than 150,000 / UL, or coagulation disorders, prothrombin time (PT value) is less than 11 seconds or greater than 16 seconds
- Leukemia, sepsis, platelet dysfunction or other blood related diseases
- tumors, infections or the trauma before the same site
- Pregnancy
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：Saline injection
Sodium Chloride injection into the study knee joint every 4 weeks for a total of 3 injections |
5ml Placebo infusion of 0.9% Sodium Chloride |
|
実験的：PRP injection
PRP injection into the study knee joint every 4 weeks for a total of 3 injections |
Device: "Aeon" Acti-PRP 5ml autologous platelet rich plasma injection |
|
実験的：PL injection
PL injection into the study knee joint every 4 weeks for a total of 3 injections Platelet lysate is the product of nature activation from autologous platelet. |
Device: "Aeon" Acti-PRP 5ml autologous platelet lysate injection |
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 |
|---|---|---|
|
Pain score of the patient
時間枠：up to 24 weeks after surgery
|
Using Visual Analog Score (from 0 to 10, 0 indicate no pain and 10 indicate maximal pain) to evaluate pain of surgical wound of the patient |
up to 24 weeks after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Knee functional score
時間枠：up to 24 weeks after surgery
|
Using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
up to 24 weeks after surgery
|
|
X-ray
時間枠：up to 24 weeks after surgery
|
Knee X-ray image |
up to 24 weeks after surgery
|
|
Ultrasonic image
時間枠：up to 24 weeks after surgery
|
Ultrasonic-between thickness of the medial and lateral sides of the femoral condyle |
up to 24 weeks after surgery
|
|
adverse events
時間枠：up to 24 weeks after surgery
|
adverse events in clinical trial |
up to 24 weeks after surgery
|
協力者と研究者
捜査官
- スタディディレクター：Wu Chueh-Hung, MD, CIPS、National Taiwan University Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。