Ultrasound Guided vs Unguided Intra-articular Knee Injections
Accuracy of Ultrasound Guided Versus Unguided Intra-articular Knee Injections in a Difficult to Inject Population
調査の概要
詳細な説明
Patients with BMI > 30 and no clinically detectable knee effusions, with clinical symptoms and radiographic evidence of knee osteoarthritis or inflammatory arthritis, who have been referred for an intraarticular knee injection with corticosteroid will be randomized to either receive ultrasound guidance or not receive ultrasound guidance for their injection. One group will use the ultrasound guidance to position the needle. The other group will use landmarks to position the needle. For both groups, once the proceduralist is comfortable with needle placement for the injection, contrast dye will be injected and fluoroscopy used, to determine if the needle placement is correct. If it is determined the needle placement is not correct, fluoroscopy will be used to reposition it. Once needle placement is determined to be acceptable, the injection will be given. Patient demographics will be collected, along with pain scores preprocedure and two weeks post-procedure.
Subjects are responsible for all clinical costs associated with the injection.
There is no remuneration offered for study participation.
研究の種類
段階
- フェーズ 3
連絡先と場所
研究場所
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Minnesota
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic in Rochester
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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
- BMI > 30
- No clinically detectable knee effusion
- Clinical or radiographic evidence of knee osteoarthritis or inflammatory arthritis
- Must be referred to the Pain Clinic for treatment
Exclusion Criteria
- History of surgery on the affected knee
- Evidence of untreated systemic infection or systemic immunocompromise
- Evidence of cutaneous infections near the study knee injection site
- Patients on warfarin with an INR > 3.0
- Patients on oral antiplatelet or anticoagulant medications will be excluded if they have documented evidence of renal insufficiency (GFR < 60)
- History of iodinated contrast allergy or significant reaction to corticosteroids or lidocaine
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 |
|---|---|
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アクティブコンパレータ：Ultrasound Machine Guided Injection
Use of ultrasound machine guidance in needle placement into the knee joint
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Use of ultrasound machine guidance for accurate needle placement into the knee joint
他の名前：
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アクティブコンパレータ：Unguided Injection
Needle placement performed without ultrasound machine guidance
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Needle placement will take place without ultrasound machine guidance
他の名前：
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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 |
|---|---|---|
|
Accuracy of the initial needle placement into the knee joint.
時間枠：During the initial needle placement, which can take 1-5 minutes
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The number of participants with accurate initial needle placement into the knee joint
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During the initial needle placement, which can take 1-5 minutes
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Improved clinical efficacy of US guided knee injections compared to unguided knee injections
時間枠：30 minutes post injection
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Comparison of VAS scores 30 minutes after injection between subjects who had ultrasound guided knee injections and those who didn't
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30 minutes post injection
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Detection of knee effusions
時間枠：During procedure, which can take up to 30 minutes to complete
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Comparison of the accuracy of detecting a knee effusion on clinical examination versus ultrasonographically
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During procedure, which can take up to 30 minutes to complete
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Matthew Pingree, MD、Mayo Clinic
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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
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。