EUCTR2016-003078-41-CZ进行中（未招募）1 期
Reduction of post-traumatic systemic inflammatory response by Phlogenzym® using total hip replacement as a model.
MUCOS Pharma CZ s.r.o.0 个研究点目标入组 40 人开始时间: 2016年9月15日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.The patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease.
- •2.The patient has signed an Informed Consent Form, approved by the EC and CA.
- •3.The patient is a male or non-pregnant female age 50 years or older at time of arthroplasty.
- •4.The patient is a candidate for a primary cementless total hip replacement
- •via anterolateral approach in spinal (subarachnoidal) anesthesia.
- •5.There are no contraindications for planned concomitant medication.
- •6.The patient is willing and able to comply with postoperative scheduled clinical evaluations and rehabilitation.
- •7.The patient agrees to abstain from smoking from the signing of the informed consent till the discharge from the hospital.
- •8.Anticipated uncomplicated operation course as per Investigator´s judgment.
- •9.Female subjects in the fertile ageWomen of childbearing potential, unless practicing sexual abstinence, must take adequate contraceptive measures: a barrier method in combination with spermicide or per-oral contraception or IUD with an exception of women who are post-menopausal or are not of child bearing potential. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1.The patient has a Body Mass Index (BMI) = 20 and =35.
- •2.The patient has an active or suspected latent infection in or about the affected hip joint at the time of the implantation.
- •3.The patient has a baseline CRP value > 6 mg/l.
- •4.The patient has been a tobacco smoker for any time within the last 12 months.
- •5.The patient has a neuromuscular or neurosensory deficiency, which limits the validity of the assessment procedures.
- •6.The patient is diagnosed with a systemic disease (e.g. rheumathoid arthritis, lupus erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
- •7.The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (at least 30 days before study).
- •8.Planned mini-incision or other than anterolateral approach operation.
- •9.The patient requires revision operation of a previously implanted total hip replacement or hip fusion to the affected joint.
- •10.The patient has a known sensitivity to device materials or Phlogenzym® or Placebo.
- •11.Pregnancy or nursing.
- •12.Insulin dependent DM.
- •13.Contraindication of Xarelto® or history of intolerance of Xarelto®.®; otherwise, there is no prohibited concomitant medication.
- •14.Participation or planned participation in another clinical study.
- •15.Inborn or acquired hemocoagulation disorders (hemophilia, severe liver dysfunction).
- •16.The patient is on hemodialysis
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