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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Percutaneous fixation by internal cemented screw (InnoFix®)
DevicePercutaneous fixation by internal cemented screw
Treatment groups
34 Participants
are divided into 1 treatment groupGroup A: Adult cancer patient with a non-displaced pelvic pathologic fractureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of patients which have a pain reduction rate, at 6 weeks postoperatively, equal or superior to 30%
Pain reduction is measured with the VAS scale : Zero is equivalent to no pain and 10 indicates the worst possible pain
Time frame
From the patient inclusion date to 6 weeks postoperativelySecondary outcomes
1
Rate of patients which have a pain reduction rate, at 6 months postoperatively, equal or superior to 30%
The pain is measured with the VAS scale: Zero is equivalent to no pain and 10 indicates the worst possible pain
Time frame
From the patient inclusion date to 6 months postoperatively2
Rate of postoperative stable fractures
Fracture stability is assessed with medical imaging: Length of fracture line in millieter (complete fracture) or fracture occurernce (impending fracture)
Time frame
From end surgery to 6 weeks and 6 months postoperatively3
Rate of patients which have a mobility improvement rate postoperatively
Mobility is measured with ECOG scale:
Time frame
From the patient inclusion date to 6 weeks and 6 months postoperatively4
Implantation success rate of the InnoFix® screw
Implantation succes is measured with medical imaging: Screw position compared to the fracture line and distance, in millimeters, of the distal tip of screw compared to the planned area and protrusion, in millimeters, of the proximal part of screw from the external cortex
Time frame
At the end of surgeryLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Innoprod Medical
Lead sponsor
EVAMED
Collaborator
Source ClinicalTrials.gov
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