Performance and Safety of the Innofix® Screw (IF25)

NCT ID: NCT06800417

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2026-05-31

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.

Conditions

Pathologic Fracture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adult cancer patient with a non-displaced pelvic pathologic fracture

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.

Group Type: EXPERIMENTAL

Percutaneous fixation by internal cemented screw (InnoFix®)

Intervention Type: DEVICE

Percutaneous fixation by internal cemented screw

Interventions

Percutaneous fixation by internal cemented screw (InnoFix®)

Percutaneous fixation by internal cemented screw

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EVAMED

OTHER

Sponsor Role: collaborator

Innoprod Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lambros TSELIKAS

Role: PRINCIPAL_INVESTIGATOR

Gustave ROUSSY Cancer Institute - Villejuif

Xavier BUY

Role: PRINCIPAL_INVESTIGATOR

BERGONIE Institute - Bordeaux

Roberto Luigi CAZZATO

Role: PRINCIPAL_INVESTIGATOR

Strasbourg Civil Hospital - Strasbourg

Central Contacts

Frédéric DESCHAMPS

Role: CONTACT

frederic.deschamps@gustaveroussy.fr

+33 (0)1 42 11 42 11

Other Identifiers

2025-A00016-43

Identifier Type: REGISTRY

Identifier Source: secondary_id

IF25

Identifier Type: -

Identifier Source: org_study_id