NCT05356637进行中（未招募）不适用
Prospective Trial of Bipolar Sealer for Reduction of Intra-Operative Blood Loss in Total Hip Arthroplasty Utilizing the Anterior Hip Approach
North Texas Medical Research Institute, PLLC4 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年4月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
- 试验地点
- 4
- 主要终点
- post-operative hemoglobin
研究概览
简要总结
The overall objectives and purpose of this study is to show that the Smith and Nephew Werewolf Fastseal 6.0 Bipolar Sealer is an effective tool to aide the surgical team in providing significant hemostasis during anterior total hip arthroplasty which would subsequently improve patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is to undergo a standard of care primary total hip replacement for degenerative joint disease. All devices are to be used according to the approved indications, this includes the FDA approved Werewolf Fastseal Bipolar Device.
- •The patient is expected to have an outpatient status and will be discharged <23 hours.
- •Individuals who are able to speak, read, and comprehend the Institutional Review Board approved Informed Consent Document and willing and able to provide informed patient consent for participation in the study.
- •Individuals who are willing and able to complete follow-up visits and questionnaires as specified by the study protocol.
- •Individuals who are not bedridden per the discretion of the investigator (The intent of "not bedridden" means a permanent situation, not a temporary situation as in a hip fracture or trauma case).
- •Individuals who are a minimum age of 21 years and less than 80 years at the time of consent.
排除标准
- •Active local or systemic infection.
- •Hematologic disease either inherited or acquired, that would predispose the patient to anemia or increased intra-operative blood loss
- •Currently taking anti-coagulation medications more than 81 mg aspirin every day.
- •Platelet disorder either inherited or acquired with a serum platelet level <150,000 platelets per microliter.
- •Coagulopathy as seen with routine lab work
- •Unstable/uncontrolled cardiovascular disease such as congestive heart failure, hypertension, or renal disease such as GFR <70, in the opinion of the investigative team and PI.
- •Excessive alcohol intake or tobacco use, in the opinion of the investigator.
- •Uncontrolled diabetes mellitus with hemoglobin a1c >7.5%.
- •Established history of previous venous thrombotic events (VTE).
- •Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
- •The subject is a woman who is pregnant or lactating.
- •Subject had a contralateral amputation.
- •Previous partial hip replacement in affected hip.
- •Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.
- •Contralateral hip was replaced less than 3 months prior to surgery date, contralateral hip is already enrolled in the study, or simultaneous or staged hip replacement is planned
- •Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
- •Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
- •Subject, in the opinion of the Investigator, is a drug or alcohol abuser or has a physical or psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
结局指标
主要结局
post-operative hemoglobin
时间窗: taken at 48-72 hours post op
obtained from point of care testing (hemocue hgb 801 device) in clinic (g/dL)
intra-operative total blood loss
时间窗: taken at time of surgery
total blood loss approximated in milliliters from measuring output in suction canister and input from fluid bags with measurement markings
次要结局
- Mean operative time ("skin to skin")(intra-operative)
- patient reported pain prescription drug usage(measured at post-operative period of 6 weeks)
- Post-operative need for transfusion(6 weeks post operative period)
- Harris Hip Score analysis 6 weeks post operative visits(measured at preop, and at 6 weeks)
- incidence of VTE(for post-operative 6 weeks)
- patient reported pain scoring(measured at preop, 2 weeks, 6 weeks)
- length of hospital stay(post-operative for 6 weeks)
研究者
Mohammad Umar Burney, MD
Principal Investigator, Clinical Medical Director
North Texas Medical Research Institute, PLLC
研究点 (4)
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