Open Label, Randomized, Blinded Study to Evaluate the Efficacy of Aquamantys System for Reducing the Transfusion Requirements Associated With the Anterior-Supine Intermuscular (ASI) Approach for Total Hip Arthroplasty (THA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Perioperative Change in Hemoglobin Level
研究概览
简要总结
The purpose of this study is to establish whether or not there is a clinical advantage to the use of Aquamantys® System from Medtronic Advanced Energy (formerly Salient Surgical Technologies) in patients undergoing primary total hip arthroplasty via the anterior supine intermuscular surgical approach in terms of blood loss, transfusion and wound healing. Wound healing will be assessed by a blinded observer and based upon a simple and subjective criteria: a) as expected, b) better than expected or c) worse than expected. The blinded observer is experienced in the care of the surgical patient and wound evaluation.
详细描述
To establish in a randomized, blinded study whether or not there is a clinical advantage to the use of Aquamantys® System from Medtronic Advanced Energy (formerly Salient Surgical Technologies) in patients undergoing primary total hip arthroplasty via the anterior supine intermuscular surgical approach in terms of blood loss, transfusion and wound healing based on early collected data. Data will be analyzed using StatsDirect in standard fashion to elucidate any difference between control and treatment groups. Wound healing will be assessed by a blinded observer and based upon a simple and subjective criteria: a) as expected, b) better than expected or c) worse than expected. The blinded observer is experienced in the care of the surgical patient and wound evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing primary unilateral total hip arthroplasty via the anterior supine intermuscular approach
- •Patient is willing and able to complete all follow-up visits at 6 weeks and 1 year
排除标准
- •Patients with pre-existing known coagulopathy
- •Patients on chronic Coumadin (Warfarin) therapy
- •Patients receiving erythropoietin therapy for anemia
结局指标
主要结局
Perioperative Change in Hemoglobin Level
时间窗: From up to 30 days preoperative through postoperative day 1
All patients will undergo routine lab work perioperatively. No additional studies will be necessary for this protocol. Hemoglobin level will be first measured preoperatively at the time of preadmission testing, which must be performed not more than 30 days prior to surgery, and then measured on postoperative day one. The two levels will be compared to assess the decrease in hemoglobin level resulting from the surgical intervention.
Perioperative Blood Transfusion Requirement
时间窗: From the beginning of surgical intervention to hospital discharge, which averages 2 days and may be up to 1 week postoperative
Perioperative blood transfusion requirements will be recorded, including transfusions administered during the surgical intervention and throughout the acute hospital stay.
Perioperative Blood Loss
时间窗: From beginning of surgical intervention through hospital discharge, which averages 2 days and may be up to 1 week
Anesthesia and nursing records will be monitored for blood loss intraoperatively, and postoperatively via drain output. Drains will be pulled daily at 0600 and measured.
次要结局
- The development of complications in the wound, either as an inpatient or after discharge(Wound evaluations will occur each postoperative day in hospital (average 2 days and up to 1 week), at 6 weeks, and 1 year.)
- Length of stay(From admission through hospital discharge (average 2 days, up to 1 week))
研究者
Keith R. Berend
Principal Investigator
Joint Implant Surgeons, Inc.