Performance and Safety of the Innofix® Screw (IF25)

NCT06800417 | Not Yet Recruiting DMC

• 2 other identifiers: IF252025-A00016-43
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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

Keywords

FICS; Pelvis; Cancer

Outcome Measures

Primary Outcomes (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

  From the patient inclusion date to 6 weeks postoperatively

Secondary Outcomes (10)

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

  From the patient inclusion date to 6 months postoperatively

• Rate of postoperative stable fractures

  From end surgery to 6 weeks and 6 months postoperatively

• Rate of patients which have a mobility improvement rate postoperatively

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

• Implantation success rate of the InnoFix® screw

  At the end of surgery

• Satisfaction rate of the radiologist regarding the efficiency of the percutaneous implementation

  At the end of surgery

Study Arms (1)

Adult cancer patient with a non-displaced pelvic pathologic fracture

EXPERIMENTAL

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.

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

Interventions

Percutaneous fixation by internal cemented screw (InnoFix®) DEVICE

Percutaneous fixation by internal cemented screw

Adult cancer patient with a non-displaced pelvic pathologic fracture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Innoprod Medical: lead
• EVAMED: collaborator

MeSH Terms

Conditions

Fractures, Spontaneous; Neoplasms

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• Lambros TSELIKAS

  Gustave ROUSSY Cancer Institute - Villejuif

  PRINCIPAL INVESTIGATOR

• Xavier BUY

  BERGONIE Institute - Bordeaux

  PRINCIPAL INVESTIGATOR

• Roberto Luigi CAZZATO

  Strasbourg Civil Hospital - Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric DESCHAMPS

CONTACT

+33 (0)1 42 11 42 11; frederic.deschamps@gustaveroussy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 30, 2025
• Study Start: May 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share