ACTRN12619000860167已完成未知
A Safety and Technical Feasibility Evaluation of the Curvafix® Intramedullary Rodscrew System for Fixation of Pelvic and Acetabular Fractures
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 26
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Subject, or their Authorized Representative, is willing and able to provide written informed
- •consent, including authorization to release health information
- •2. Subject is >18 years and < 70 years of age (inclusive) at time of consent
- •3. Subject has an unstable pelvic or acetabular displaced fracture in which fixation with one
- •or more large cannulated screw(s) is recommended
- •4. Subject’s pelvic or acetabular fracture occurred (injury) within 14 days of procedure
- •5. Subject has provided a negative pregnancy test (if of child bearing age or potential) and
- •is willing to continue an effective method of birth control through study end (6 months)
- •6. Subject is a suitable candidate for cannulated screw fixation
排除标准
- •1. Subject is unwilling or unable to provide written informed consent and/or does not have
- •an authorized representative who can provide consent on their behalf
- •2. Subject has an open pelvic or acetabular fracture (where the bone is exposed)
- •3. Subject has an active significant or local infection at the time of the procedure that may compromise study results (for example, a sinus infection would not be considered an exclusion)
- •4. Subject has muscular deficit, neurological deficiency, or behavioral disorders which could submit the osteosynthesis to abnormal mechanical strains
- •5. Subjects has malignant primary or metastatic cancer or subject has undergone recent chemotherapy or other treatment that have resulted in compromised bone density
- •6. Subject has a tumor(s) which precludes adequate bone support or screw fixation(s)
- •7. Subject has a sensitivity or uncontrollable allergy to the study device or other materials necessary to perform the procedure
- •8. Subject’s pelvis intracortical space is not large enough to accommodate the study device
- •9. Subject’s pelvic and/or acetabular size and/or shape is not appropriate for CurvaFix implantation
- •10. Subject has had previous pelvic ring and/or acetabular surgery which mechanically precludes the implantation of a rodscrew
- •11. Subject has a history of osteoporosis that is considered severe or, in the opinion of the physician, would compromise study results
- •12. The fracture pattern is not appropriate for intramedullary fixation (e.g. posterior or anterior wall fractures in isolation)
- •13. Subject plans to have additional surgical procedure(s) within 6 months of the CurvaFix procedure that in the opinion of the investigator would interfere with study results
- •14. Subject is considered obese or morbidly obese and/or with a body shape that prevents the necessary pelvic access
- •15. Subject has a vascular injury at the fracture site that the investigator feels could interfere with the procedure
- •16. Subject is under incarceration or the subject’s fracture injury is or may be related to criminal activity
- •17. Subject is pregnant, nursing, or plans to become pregnant during the study, or is not willing to use an effective method of birth control (if of child bearing age and potential)
- •18. Subject is enrolled in an investigational drug or device study or has participated in such a study within the last 30 days prior to screening that in the opinion of the investigator would interfere with the study results
- •19. Subject presents with any condition or situation which, in the Investigator’s opinion, puts the Subject at risk, could confound the study results, or may interfere with the Subject’s participation in the study
研究者
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