Performance and Safety of the Innofix® Screw (IF25)

Innoprod Medical

Status: Not yet enrolling

Conditions: Pathologic Fracture

Treatments: Device: Percutaneous fixation by internal cemented screw (InnoFix®)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06800417

IF25

2025-A00016-43 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Adult cancer patient with a non-displaced pelvic pathologic fracture

Experimental group

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.

Treatment:

Device: Percutaneous fixation by internal cemented screw (InnoFix®)