DRKS00007564招募中4 期
Randomized Controlled Trial to determine the efficacy of EVICEL® on blood loss in orthopaedic surgery after total knee replacement (TKR)
Medizinische Hochschule Hannover0 个研究点目标入组 68 人开始时间: 2014年11月26日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 55 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1. Males or females aged from 55 to 70 years at the day of the operation.
- •2. Patients with the indication for primary TKR on the basis of diagnosed osteoarthritis, arthritis or avascular necrosis.
- •3. Patients with intact medial and lateral collateral ligaments (to be diagnosed in the preoperative examination) who are planned to receive a prosthesis of the Stryker Triathlon CR or Triathlon PS ® system in the preoperative planning.
- •4. Patients willing to participate in this randomized controlled trial (RCT) and having signed the informed consent approved by the ethics committee.
排除标准
- •1. Patients participating in any other clinical trial within 30 days before inclusion or concurrent to this study.
- •2 Pregnant or nursing women
- •3. Patients tested positive for HIV, Hep B and C
- •4. Patients with documented or suspected hypersensitivity to any of the active substances or excipients of EVICEL® or to bone cement or its components.
- •5. Patients with acute or suspected coagulation disorders and patients with preoperative blood parameters INR>1,4 or PTT > 40 s.
- •6. Concomitant medication within 7 days before surgery with substances that affect haemostasis, except for low molecular weight heparins or alternatives in prophylactic dosage indicated for standard thrombosis prophylaxis.
- •7. Anemic patients showing preoperative Hb levels < 11 g/dl.
- •8. Patients with a deficit in extension of >15° or with a maximal flexion of less than 90°
- •9. Highly obese people (BMI>35).
- •10. Patients suffering from neuromuscular or neurosensoric diseases.
- •11. Patients with known active tumour disease or tumour related diseases.
- •12. Patients suffering from any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
- •13. Patients receiving a prosthesis different to the Stryker Triathlon CR or Triathlon PS system due to intraoperative circumstances (such as bone fractures or ligament insufficiencies)
- •14. Intraoperative deviation from the agreed haemostatic procedure (e.g. use of the
- •tourniquet deviant from the agreement, e. g. in case of surgery lasting more than 2 hours). Patients with surgery lasting more than two 2 hours will not be randomized.
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