System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Studies

Interventional Not yet recruiting

NCT06800417 on ClinicalTrials.gov

Performance and Safety of the Innofix® Screw (IF25)

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

  • Sponsor: Innoprod Medical
  • Collaborators: EVAMED
  • Enrollment: 34 (Estimated)
  • Study start: 2025-05-01 (Estimated)
  • Primary completion: 2026-01-01 (Estimated)
  • Study completion: 2026-05-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Treatment

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

Intervention / Treatment

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

Primary Outcome Measures

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

Study Officials