Performance and Safety of the Innofix® Screw (IF25)

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Percutaneous fixation by internal cemented screw (InnoFix®)
  Percutaneous fixation by internal cemented screw

Первичные конечные точки

• Rate of patients which have a pain reduction rate, at 6 weeks postoperatively, equal or superior to 30% [Срок оценки: From the patient inclusion date to 6 weeks postoperatively]

Вторичные конечные точки (10)

• Rate of patients which have a pain reduction rate, at 6 months postoperatively, equal or superior to 30% [Срок оценки: From the patient inclusion date to 6 months postoperatively]
• Rate of postoperative stable fractures [Срок оценки: From end surgery to 6 weeks and 6 months postoperatively]
• Rate of patients which have a mobility improvement rate postoperatively [Срок оценки: From the patient inclusion date to 6 weeks and 6 months postoperatively]
• Implantation success rate of the InnoFix® screw [Срок оценки: At the end of surgery]
• Satisfaction rate of the radiologist regarding the efficiency of the percutaneous implementation [Срок оценки: At the end of surgery]
• Satisfaction rate of the radiologist regarding the efficiency of the percutaneous cementing [Срок оценки: At the end of surgery]
• Rate of stable InnoFix® screws postoperatively [Срок оценки: From end surgery to 6 weeks and 6 months postoperatively]
• Rate of InnoFix® screws with their integrity preserved postoperatively [Срок оценки: From end surgery to 6 weeks and 6 months postoperatively]
• Rate of patient which have had, at least, one adverse event in relation with the InnoFix® screw postoperatively [Срок оценки: 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 [Срок оценки: From the patient inclusion date to 6 months postoperatively]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06800417 · IF25 · 2025-A00016-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗