Clinical trials

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Condition / disease
Location
Status: Not yet recruiting

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.

Participants needed: 34
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Innoprod MedicalUpdated: Jan 30, 2025
Eligibility criteria

The patient is 18 years old or more [+6]

The patient has got a displaced fracture or an unstable fracture justifying conv... [+14]