Performance and Safety of the Innofix® Screw (IF25) (NCT06800417) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Performance and Safety of the Innofix® Screw (IF25)
34 participantsStarted 2025-05
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of patients which have a pain reduction rate, at 6 weeks postoperatively, equal or superior to 30%
Timeframe: From the patient inclusion date to 6 weeks postoperatively