Prospective Evaluation of Vitagel for Reduction in Blood Loss and Pain Following Unilateral Total Knee Arthroplasty
Vitagel® is an FDA approved class III medical device. It is a surgical hemostat, which has been shown to control bleeding during orthopaedic, cardiac, hepatic, and general surgical procedures. The product is a thrombin/collagen suspension which works in combination with the patient's own plasma to form a fibrin/collagen clot.
The present prospective, randomized controlled trial is designed to evaluate the efficacy of Vitagel® for reducing blood loss and pain in patients managed with unilateral total knee arthroplasty (TKA). It is hypothesized that the use of Vitagel® may lead to less blood filled knees, and thus to a greater improvement in postoperative pain scores when compared to the control group. The two arms of the study will include:
- experimental group in which Vitagel® is used unilateral TKA
- control group representing our current standard of care (no Vitagel®)
A comparison of the functional and clinical results between these two groups will be conducted using several outcome measures including the KOOS, SF-12 version2 and pain scores through the previously IRB approved OrthoMidas registry. The primary variable of interest is blood loss, based on hemoglobin drop during the postoperative hospital stay. Of secondary interest will be; 1) pain levels in the PACU, 2) pain scores for all postoperative days, 3) average pain for the entire hospital stay, 4) length of stay, 5) patient satisfaction at discharge, 4 weeks postoperative, and 12 weeks postoperative, and 6) functional scores at 4 and 12 weeks postoperative.
調査の概要
詳細な説明
This is a prospective, single-center, randomized, double-blinded, clinical trial involving three orthopaedic surgeons who perform total knee replacement. The proposed study is optimal for obtaining clinical and functional comparisons between TKA surgical procedures utilizing conventional practices (control) and TKA utilizing Vitagel®, a surgical hemostat used to control bleeding and facilitate healing. The study will include patients that are receiving a unilateral primary TKA.
Fifty cases will be assigned to each arm of the study (total 100 cases). This sample size was estimated using an alpha of 0.05 (conventional for all studies) and a beta of 0.80 (recommended for superiority studies). The standard deviation is based on a study conducted by the PI at the Cleveland Clinic in an IRB approved retrospective project in 2007, and will provide in excess of 80 percent statistical power in detecting less than a 100 ml difference in blood loss between the two groups.
The study will be conducted at the Cleveland Clinic (Cleveland, OH). The patients will not be informed of their treatment assignment, and the research investigator making observations and recording the data postoperatively will also be blinded to their treatment assignment. The placement of patients into treatment arms will be based on random drawing of sealed envelopes. An assessment of blinding will be conducted at the conclusion of the study by asking patients what treatment they think that they received.
Data will be collected at four timepoints, including preoperatively, during the hospital stay, 4 weeks postoperatively, and 12 weeks postoperatively. Preoperative data collected will include baseline SF-12, KOOS, hemoglobin and hematocrit levels, and pain scores. Data collected in the hospital will include hemoglobin and hematocrit levels, pain scores, narcotics usage, length of stay, and patient satisfaction at discharge. The SF-12, KOOS, pain scores, and patient satisfaction will be collected utilizing the 4 week (±2 weeks) standard of care postoperative visit. Patients are not always seen at the 12 week (±4 weeks) postoperative timepoint as standard of care. To collect these data, patients will be mailed the SF-12, KOOS, pain scores, patient satisfaction, and blinding assessment questionnaires. Patients not responding to the initial mailer will be contacted by phone and sent a second packet of questionnaires.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Ohio
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Cleveland、Ohio、アメリカ、44195
- The Cleveland Clinic
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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:
- Age: 18 - 85 years
- Sex: Both male and female will be included. The male-to-female ratio will depend upon the patient population.
- Stable Health: At the time of surgery based on physical examination and medical history.
- Patient exhibited preoperative radiographic evidence of joint degeneration consistent with TKA that could not have been treated in non-operative fashion.
- Patient had severe knee pain and disability due to degenerative joint disease.
- Patient or patient's legal representative has signed the Informed Consent form. The patient is capable of making informed decisions regarding his/her healthcare.
Exclusion Criteria:
- Patients with history of liver disease. Patients with liver dysfunction from cirrhosis or hepatitis may have impaired production of factors in the clotting cascade which may make these individuals more prone to bleed, especially with the use of anticoagulants. For this reason, these patients will also be excluded from this study if a baseline INR if greater than 1.3.
- Patients allergic to materials of bovine origin.
- Patients predonating autologous blood.
- Patients with a preoperative platelet count of less than 100,000.
- Patients undergoing bilateral or revision surgery.
- Evidence of bleeding or metabolic - based hemolytic disorder (hemophilia or anticoagulation use), or hypercoaguable disorder.
- Previous history of infection in the affected joint.
- Peripheral vascular disease.
- Patient was a poor compliance risk - treated for ethanol or drug abuse, physical or mental handicap, etc.
- Patients with a previous history of venous thromboembolism, or other reason for requiring anticoagulation other than ASA 325 mg po BID and mechanical compression.
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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実験的：Vitagel
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Vitagel applied just prior to closure during primary total knee arthroplasty
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介入なし：Control
No Vitagel used.
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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 |
時間枠 |
|---|---|
|
輸血で管理された患者数
時間枠：入院中毎日（平均4日程度）
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入院中毎日（平均4日程度）
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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 |
|---|---|---|
|
滞在日数
時間枠：退院日
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退院日
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|
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ペインスコアスケール
時間枠：手術前30日以内（術前）、手術後4週間、手術後12週間以内
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0 から 10 の整数スケールで全体的な痛みを評価するために使用される単一のスコアリング システム。0 は「痛みなし」を表し、10 は「耐え難い痛み」を表します。
したがって、このコンテキストでは、値が低いほど良い結果を表します。
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手術前30日以内（術前）、手術後4週間、手術後12週間以内
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Total Calculated Hospital Blood Loss
時間枠：daily during hospital stay (an expected average of 4 days)
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daily during hospital stay (an expected average of 4 days)
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Preoperative & Postoperative Hemoglobin Values
時間枠：within 30 days before surgery (preop), daily during hospital stay (an expected average of 4 days)
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within 30 days before surgery (preop), daily during hospital stay (an expected average of 4 days)
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Daily Narcotic Usage (Morphine-equivalent mg)
時間枠：daily during hospital stay (an expected average of 4 days)
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daily during hospital stay (an expected average of 4 days)
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Knee Injury and Osteoarthritis Outcome Score (KOOS)
時間枠：within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery
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A scoring system used to evaluate the patient's opinion about his/her knee and associated problems.
Subscales include 1) pain, 2) other symptoms, 3) function in daily living (ADL), 4) function in sport and recreation (Sport/Rec), and 5) knee related quality of life (QOL).
Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score between 0 to 100 is calculated for each subscale.
Subscale scores are generally not combined; rather, they are reported separated.
Higher values represent better outcomes (i.e., less extreme symptoms).
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within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery
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協力者と研究者
スポンサー
出版物と役立つリンク
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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