NCT06800417尚未招募不适用
Performance and Safety of the Innofix® Screw as Part of Stabilization of a Non-displaced Pathologic Fracture (Complete or Impending) of the Pelvic Bone of Cancer Patients by Mini-invasive Percutaneous Fixation by Internal Cemented Screw
Innoprod Medical0 个研究点目标入组 34 人开始时间: 2025年5月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 主要终点
- Rate of patients which have a pain reduction rate, at 6 weeks postoperatively, equal or superior to 30%
研究概览
简要总结
The purpose of this clinical investigation is to collect data about the safety and the performances of the InnoFix® screw : Clinical performances (Pain reduction due to the fracture treatment, maintenance of the stabilizaton of the treated fracture and mobility improvement) / Technical performances (Percutaneous implantation by mini-invasive approach, Efficiency of percutaneous implementation and efficiency of percuatneous cementing) / Safety performances (Preservation of the screw stability after implantation and preservation of the screw integrity after implantation). The safety and performance data about the InnoFix® screw will be used to obtain their CE marking according to the regulation (EU) 2017/745.
The principal objective of this clinical investigation is to assess the postoperative reduction in pain level of the patient at 6 weeks follow-up.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is 18 years old or more
- •The patient is a cancer patient
- •The patient needs a stabilization of a non-displaced pathologic fracture (complete or impending) of the pelvic bone
- •The patient is symptomatic with musculoskeletal pain exacerbated during movement or weight bearing
- •The patient has been informed and he has signed the informed consent
- •The patient must be willing and able to comply with all study requirements including follow-up visits and radiographic assessments
- •The patient is affiliated with the French social security system
排除标准
- •The patient has got a displaced fracture or an unstable fracture justifying conventional surgical fixation
- •The patient is a pregnant woman or considered getting pregnant during its investigation participation
- •The patient presents medical conditions that could have an impact on the clinical investigation (under responsibility of the investigator)
- •The patient has got one or more contraindications to general anaesthesia
- •The patient has got an insufficient bone strength (severe osteoporosis, local infection, or tumor osteolysis) precluding a correct and long-term fixation
- •The use of the InnoFix® screw can interfere with anatomical structures or physiological performances
- •The patient has got an insufficient tissue coverage at the surgical site
- •The patient has got a sepsis, fever, subcutaneous or cutaneous infection on the implantation way, deep abscess in contact with the fracture site
- •The patient has got a mental or neuromuscular disorder that may cause fixation failure or postoperative complications
- •The patient is allergic and/or hypersensitive to a component of the InnoFix® modules, of the InnoTool™ instruments and to the used cement
- •The patient has got a haemostasis disorder ((INR >1.5, platelets <50x109/L)
- •The patient participates to another clinical investigation
- •The patient's life expectancy is lower than 6 months
- •The patient is under guardianship, curatorship or legal protection
- •The patient is deprived of liberty by a judicial or administrative decision
结局指标
主要结局
Rate of patients which have a pain reduction rate, at 6 weeks postoperatively, equal or superior to 30%
时间窗: From the patient inclusion date to 6 weeks postoperatively
Pain reduction is measured with the VAS scale : Zero is equivalent to no pain and 10 indicates the worst possible pain
次要结局
- Implantation success rate of the InnoFix® screw(At the end of surgery)
- Rate of InnoFix® screws with their integrity preserved postoperatively(From end surgery to 6 weeks and 6 months postoperatively)
- Satisfaction rate of the radiologist regarding the efficiency of the percutaneous implementation(At the end of surgery)
- Satisfaction rate of the radiologist regarding the efficiency of the percutaneous cementing(At the end of surgery)
- Rate of stable InnoFix® screws postoperatively(From end surgery to 6 weeks and 6 months postoperatively)
- Rate of patients which have a pain reduction rate, at 6 months postoperatively, equal or superior to 30%(From the patient inclusion date to 6 months postoperatively)
- Rate of patient which have had, at least, one adverse event in relation with the InnoFix® screw postoperatively(From the patient inclusion date to 6 months postoperatively)
- Rate of patient which have had, at least, one serious adverse event in relation with the InnoFix® screw postoperatively(From the patient inclusion date to 6 months postoperatively)
- Rate of postoperative stable fractures(From end surgery to 6 weeks and 6 months postoperatively)
- Rate of patients which have a mobility improvement rate postoperatively(From the patient inclusion date to 6 weeks and 6 months postoperatively)
研究者
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