Clinical trial · Interventional
Performance and Safety of the Innofix® Screw (IF25)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pathologic Fracture | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Percutaneous fixation by internal cemented screw (InnoFix®) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adult cancer patient with a non-displaced pelvic pathologic fracture
- description
- The fracture of the patients, treated with InnoFix® screw, is stabilized with a percutaneous fixation by internal cemented screw. This procedure is carried out by mini-invasive approach.
- interventionNames
- Device: Percutaneous fixation by internal cemented screw (InnoFix®)
Primary outcomes (1)
- measure
- 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
- description
- Pain reduction is measured with the VAS scale : Zero is equivalent to no pain and 10 indicates the worst possible pain
Secondary outcomes (10)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 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
References
Publications (0)
Data not yet available