Performance and Safety of the Innofix® Screw (IF25)
ConditionPathologic Fracture
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnoprod Medical
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Percutaneous fixation by internal cemented screw (InnoFix®)
Treatment groups
34 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Innoprod Medical
Lead sponsor
EVAMED
Collaborator
Source ClinicalTrials.gov