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Performance and Safety of the Innofix® Screw (IF25)

NCT06800417 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-01-30

No results posted yet for this study

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

Interventions

DEVICE

Percutaneous fixation by internal cemented screw (InnoFix®)

Percutaneous fixation by internal cemented screw

Sponsors & Collaborators

  • EVAMED

    collaborator OTHER

  • Innoprod Medical

    lead INDUSTRY

Principal Investigators

  • Lambros TSELIKAS · Gustave ROUSSY Cancer Institute - Villejuif

  • Xavier BUY · BERGONIE Institute - Bordeaux

  • Roberto Luigi CAZZATO · Strasbourg Civil Hospital - Strasbourg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2026-01-31
Completion
2026-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06800417 on ClinicalTrials.gov