Clinical trial NCT06800417: Performance and Safety of the Innofix® Screw (IF25)
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pathologic Fracture
Keywords: FICS
Pelvis
Cancer
Lead sponsor: Innoprod Medical
Sponsor class: INDUSTRY
Collaborators: name: EVAMED
First posted: 2025-01-30
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
measure: Rate of patients which have a pain reduction rate, at 6 months postoperatively, equal or superior to 30%
timeFrame: From the patient inclusion date to 6 months postoperatively
measure: Rate of postoperative stable fractures
timeFrame: From end surgery to 6 weeks and 6 months postoperatively
measure: Rate of patients which have a mobility improvement rate postoperatively
timeFrame: From the patient inclusion date to 6 weeks and 6 months postoperatively
measure: Implantation success rate of the InnoFix® screw
timeFrame: At the end of surgery
measure: Satisfaction rate of the radiologist regarding the efficiency of the percutaneous implementation
timeFrame: At the end of surgery
measure: Satisfaction rate of the radiologist regarding the efficiency of the percutaneous cementing
timeFrame: At the end of surgery
measure: Rate of stable InnoFix® screws postoperatively
timeFrame: From end surgery to 6 weeks and 6 months postoperatively
measure: Rate of InnoFix® screws with their integrity preserved postoperatively
timeFrame: From end surgery to 6 weeks and 6 months postoperatively
measure: Rate of patient which have had, at least, one adverse event in relation with the InnoFix® screw postoperatively
timeFrame: From the patient inclusion date to 6 months postoperatively
measure: Rate of patient which have had, at least, one serious adverse event in relation with the InnoFix® screw postoperatively
timeFrame: From the patient inclusion date to 6 months postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Gustave ROUSSY Cancer Institute - Villejuif
name: Lambros TSELIKAS
role: PRINCIPAL_INVESTIGATOR
affiliation: BERGONIE Institute - Bordeaux
name: Xavier BUY
role: PRINCIPAL_INVESTIGATOR
affiliation: Strasbourg Civil Hospital - Strasbourg
name: Roberto Luigi CAZZATO
role: PRINCIPAL_INVESTIGATOR
References: