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Performance and Safety of the Innofix® Screw (IF25)

Study acronym: IF25
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 30, 2025 (before its estimated January 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT06800417
Lead Sponsor Innoprod Medical
Collaborators: EVAMED
Conditions
(from sponsor)		 Pathologic Fracture
Related terms Fractures, Spontaneous, Neoplasms
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov