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Pathologic FractureIF25NCT06800417

Performance and Safety of the Innofix® Screw (IF25)

A study testing Percutaneous fixation by internal cemented screw (InnoFix®) in people with Pathologic Fracture, run by Innoprod Medical.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pathologic Fracture
What is being tested?
Percutaneous fixation by internal cemented screw (InnoFix®)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
No sites listed yet
Study dates
May 2025to May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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 locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Frédéric DESCHAMPS contact

+33 (0)1 42 11 42 11

frederic.deschamps@gustaveroussy.fr

About this study

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

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.

Being tested
Percutaneous fixation by internal cemented screw (InnoFix®)
Keywords
FICS, Pelvis, Cancer
Medical subject headings
Fractures, Spontaneous, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Percutaneous fixation by internal cemented screw

Study groups in NCT06800417
Study groupRoleWhat they receive
Adult cancer patient with a non-displaced pelvic pathologic fractureExperimentalThe 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.
Receives: Device: Percutaneous fixation by internal cemented screw (InnoFix®)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: From the patient inclusion date to 6 weeks postoperatively

Secondary outcomes (10)

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

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

    Measured: From the patient inclusion date to 6 months postoperatively

  2. Rate of postoperative stable fractures

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

    Measured: From end surgery to 6 weeks and 6 months postoperatively

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

    Mobility is measured with ECOG scale:

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

  4. Implantation success rate of the InnoFix® screw

    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

    Measured: At the end of surgery

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

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

    Measured: At the end of surgery

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

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

    Measured: At the end of surgery

  7. Rate of stable InnoFix® screws postoperatively

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

    Measured: From end surgery to 6 weeks and 6 months postoperatively

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

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

    Measured: From end surgery to 6 weeks and 6 months postoperatively

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

    Adverse event reported

    Measured: From the patient inclusion date to 6 months postoperatively

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

    Serious adverse event reported

    Measured: From the patient inclusion date to 6 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2025
  2. Study startMay 2025 (estimated)
  3. Primary completionJan 2026 (estimated)
  4. Study completionMay 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06800417
Sponsor's protocol ID
IF25
Other IDs
2025-A00016-43
Acronym
IF25
Status last verified
Jan 2025
First submitted
17 Jan 2025
Last updated
30 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Sponsor commitment to not transfert data outside the European Union

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous fixation by internal cemented screw (InnoFix®) in people with Pathologic Fracture, run by Innoprod Medical.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Frédéric DESCHAMPS (+33 (0)1 42 11 42 11, frederic.deschamps@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06800417.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.

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