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NCT Number: NCT06800417

Performance and Safety of the Innofix® Screw (IF25)

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.

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Key information

Conditions

Pathologic Fracture Fractures, Bone Fractures, Spontaneous Neoplasms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous fixation by internal cemented screw (InnoFix®)

Device

Percutaneous fixation by internal cemented screw

Primary outcomes

  1. Rate of patients which have a pain reduction rate, at 6 weeks postoperatively, equal or superior to 30%

    Time frame: From the patient inclusion date to 6 weeks postoperatively

    Pain reduction is measured with the VAS scale : Zero is equivalent to no pain and 10 indicates the worst possible pain

Secondary outcomes

  1. Rate of patients which have a pain reduction rate, at 6 months postoperatively, equal or superior to 30%

    Time frame: From the patient inclusion date to 6 months postoperatively

    The pain is measured with the VAS scale: Zero is equivalent to no pain and 10 indicates the worst possible pain

  2. Rate of postoperative stable fractures

    Time frame: From end surgery to 6 weeks and 6 months postoperatively

    Fracture stability is assessed with medical imaging: Length of fracture line in millieter (complete fracture) or fracture occurernce (impending fracture)

  3. Rate of patients which have a mobility improvement rate postoperatively

    Time frame: From the patient inclusion date to 6 weeks and 6 months postoperatively

    Mobility is measured with ECOG scale:

  4. Implantation success rate of the InnoFix® screw

    Time frame: At the end of surgery

    Implantation succes is measured with medical imaging: Screw position compared to the fracture line and distance, in millimeters, of the distal tip of screw compared to the planned area and protrusion, in millimeters, of the proximal part of screw from the external cortex

  5. Satisfaction rate of the radiologist regarding the efficiency of the percutaneous implementation

    Time frame: At the end of surgery

    Efficiency of percutaneous implementation is based on the experiency of the radaiologist

  6. Satisfaction rate of the radiologist regarding the efficiency of the percutaneous cementing

    Time frame: At the end of surgery

    Efficiency of percutaneous cementing is based on the experiency of the radaiologist

  7. Rate of stable InnoFix® screws postoperatively

    Time frame: From end surgery to 6 weeks and 6 months postoperatively

    Screw stability is measured with medical imaging: Screw displacement in millimeters and contact with anatomical structures or other implanted devices

  8. Rate of InnoFix® screws with their integrity preserved postoperatively

    Time frame: From end surgery to 6 weeks and 6 months postoperatively

    Screw integrity is measured with medical imaging: Disassembly, breakage or bending in millimeters

  9. Rate of patient which have had, at least, one adverse event in relation with the InnoFix® screw postoperatively

    Time frame: From the patient inclusion date to 6 months postoperatively

    Adverse event reported

  10. Rate of patient which have had, at least, one serious adverse event in relation with the InnoFix® screw postoperatively

    Time frame: From the patient inclusion date to 6 months postoperatively

    Serious adverse event reported

Study contacts

Contact information is provided by the study sponsor or research team.

Frédéric DESCHAMPS

CONTACT

[email protected]

+33 (0)1 42 11 42 11

Sponsors and collaborators

Lead sponsor

Innoprod Medical

Industry

Collaborators

  • EVAMED

Registry information

Official study 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

Acronym: IF25

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2025
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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